Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 11B, Software Version: 12.0.0.932.
2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221.
3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68.
4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12.
5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2492-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 12A, Software Version: 13.0.0.1547.
2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144.
3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2493-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2.
2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7.
3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2494-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 2023B, Software Version: 14.0.0.3338.
2. RayStation 2024A, Software Version: 15.0.0.430.
3. RayStation 2024A SP3, Software Version: 15.1.3.10.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2495-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jun 16, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Reason: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Root cause: Under Investigation by firm
Recalling firm: Medtronic MiniMed, Inc.Type: Calculator, Drug DoseDistribution: International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.Recall #Z-2496-2025 Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 22, 2025
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code:
V15-7-000022 / 99577-001957 / 883873871690
V15-2-000051 / 99577-000046 / 883873988022
V15-2-000099 / 99577-000093 / 883873979020
V15-2-001603 / 99577-001256 / 883873911631
LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Root cause: Under Investigation by firm
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S. Nationwide distribution in the states of CO and MT.Recall #Z-2497-2025 Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 22, 2025
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code:
320371500023 / 99425-000025 / 885074698953
320371500229 / 99425-000025 / 885074698953
331706400001 / 99425-000025 / 885074698953
LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.
ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Root cause: Under Investigation by firm
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S. Nationwide distribution in the states of CO and MT.Recall #Z-2498-2025 Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 22, 2025
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code:
CR2-2-001451 99512-001434 883873785911
LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).
The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older.
The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Root cause: Under Investigation by firm
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S. Nationwide distribution in the states of CO and MT.Recall #Z-2499-2025 Open, ClassifiedPosted Sep 2, 2025·Initiated Oct 4, 2023
Blood Uric Acid Monitoring System
Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Reason: Due to products distributed without premarket clearance or approvals.
Root cause: No Marketing Application
Recalling firm: Visgeneer, Inc.Type: Uric Acid Test System For At Home Prescription UseDistribution: Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.Recall #Z-2500-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Oct 4, 2023
Blood Uric Acid Monitoring System
Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Reason: Due to products distributed without premarket clearance or approvals.
Root cause: No Marketing Application
Recalling firm: Visgeneer, Inc.Type: Uric Acid Test System For At Home Prescription UseDistribution: Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.Recall #Z-2501-2025
Open, ClassifiedPosted Aug 29, 2025·Initiated Aug 4, 2025
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Root cause: Software design (manufacturing process)
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US distribution including Puerto Rico and OUS (International) CanadaRecall #Z-2332-2025
Open, ClassifiedPosted Aug 29, 2025·Initiated Aug 4, 2025
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Root cause: Software design (manufacturing process)
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US distribution including Puerto Rico and OUS (International) CanadaRecall #Z-2333-2025
Open, ClassifiedPosted Aug 29, 2025·Initiated Aug 4, 2025
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Root cause: Software design (manufacturing process)
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US distribution including Puerto Rico and OUS (International) CanadaRecall #Z-2334-2025
Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2426-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2427-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2428-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2429-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2430-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2431-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2432-2025