Open, ClassifiedPosted Jun 27, 2025·Initiated May 30, 2025
Servo-n Ventilator System. Model Number: 6694800.
Reason: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Root cause: Under Investigation by firm
Recalling firm: Maquet Critical Care ABType: Ventilator, Continuous, Facility UseDistribution: US Nationwide distribution and Puerto Rico. No international distribution.Recall #Z-2014-2025 Open, ClassifiedPosted Jun 27, 2025·Initiated May 30, 2025
Servo-u MR Ventilator System. Model Number: 6888800.
Reason: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Root cause: Under Investigation by firm
Recalling firm: Maquet Critical Care ABType: Ventilator, Continuous, Facility UseDistribution: US Nationwide distribution and Puerto Rico. No international distribution.Recall #Z-2015-2025 Open, ClassifiedPosted Jun 27, 2025·Initiated May 15, 2025
ARTIS is a family of dedicated angiography systems developed for single and
biplane diagnostic imaging and interventional procedures including, but not
limited to, pediatric and obese patients. Procedures that can be performed
with the ARTIS family include cardiac angiography, neuro-angiography, general
angiography, rotational angiography, multipurpose angiography and whole
body radiographic/fluoroscopic procedures as well as procedures next to the
table for i.e., patient extremities. This does not include projection radiography.
Additional procedures that can be performed include angiography in the
operating room, image guided surgery by X-ray, by image fusion, and by
navigation systems. The examination table as an integrated part of the system
can be used for X-ray imaging, surgery and interventions. ARTIS can also
support the acquisition of position triggered imaging for spatial data synthesis.
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide.Recall #Z-2019-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 15, 2025
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide.Recall #Z-2020-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 15, 2025
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide.Recall #Z-2021-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 15, 2025
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide.Recall #Z-2022-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 9, 2025
Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: (1) 6802413, (2) 6802915
Reason: A software anomaly allows test results to be reported using Micro Tip and Micro Slide
diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if
a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in
which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was
not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or
delaying test results.
Root cause: Software design
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.Recall #Z-2038-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 9, 2025
Brand Name: VITROS;
Product Name: VITROS XT 7600 Integrated System;
Model/Catalog Number: (1) 6844461, (2) 6272222;
Software Version: version 3.2 to version 3.8.3 (all available software versions);
Product Description: In vitro diagnostic chemistry analyzer.
Reason: a software anomaly allows test results to be reported using Micro Tip and Micro Slide
diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if
a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in
which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was
not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or
delaying test results.
Root cause: Software design
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.Recall #Z-2039-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 9, 2025
Brand Name: VITROS
Product Name: VITROS 4600 Chemistry System
Model/Catalog Number: (1) 6802445, (2) 6900440
Software Version: version 3.2 to version 3.8.3 (all available software versions)
Product Description: In vitro diagnostic chemistry analyzer.
Reason: a software anomaly allows test results to be reported using Micro Tip and Micro Slide
diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if
a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in
which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was
not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or
delaying test results.
Root cause: Software design
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.Recall #Z-2040-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 6, 2025
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Reason: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Root cause: Nonconforming Material/Component
Recalling firm: Hardy DiagnosticsType: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarDistribution: US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV.Recall #Z-2041-2025
Open, ClassifiedPosted Jun 27, 2025·Initiated May 20, 2025
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003.
It is a component of a Custom Constrained Shoulder Arthroplasty Device
Reason: Required inspections were not performed on finished product prior to release and distribution.
Root cause: Process control
Recalling firm: Onkos Surgical, Inc.Type: Total Shoulder Arthroplasty SystemDistribution: US Nationwide distribution in the state of Maryland.Recall #Z-2042-2025
Open, ClassifiedPosted Jun 26, 2025·Initiated May 16, 2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Reason: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
Root cause: Software design (manufacturing process)
Recalling firm: GE Medical Systems China Co., Ltd.Type: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution.Recall #Z-2029-2025
Open, ClassifiedPosted Jun 26, 2025·Initiated May 16, 2025
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers:
1) Versana Premier R3 VS, Model/Catalog Number 5938558;
2) Versana Premier R3 VA, Model/Catalog Number 5938559;
3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560;
4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561;
5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387;
6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481.
7) Versana Premier R3 Expert, Model/Catalog Number 5946950;
8) Versana Premier R3, Model/Catalog Number 5946951;
9) Versana Premier R3 Pro, Model/Catalog Number 5946952;
10) Versana Premier R3 Elite, Model/Catalog Number 5946953;
11) Versana Premier R3 Plus, Model/Catalog Number 5946954;
12) Versana Premier R3 Ultra, Model/Catalog Number 5946955;
13) Versana Premier R3 Max, Model/Catalog Number 5946956;
14) Versana Premier R3 Super, Model/Catalog Number 5946957;
15) Versana Premier R3 VS India, Model/Catalog Number 5948398;
16) Versana Premier R3 VA India, Model/Catalog Number 5948399;
diagnostic ultrasound system
Reason: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
Root cause: Software design (manufacturing process)
Recalling firm: GE Medical Systems China Co., Ltd.Type: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution.Recall #Z-2030-2025
Open, ClassifiedPosted Jun 26, 2025·Initiated May 23, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Reason: The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Root cause: No Marketing Application
Recalling firm: Jewel Precision Sheet Metal & Machining Co, Inc.Type: Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesDistribution: US distribution to Tennessee.Recall #Z-2033-2025
Open, ClassifiedPosted Jun 26, 2025·Initiated May 29, 2025
Spectral CT. Computed tomography X-ray system.
Reason: Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Root cause: Under Investigation by firm
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.Recall #Z-2034-2025 Open, ClassifiedPosted Jun 25, 2025·Initiated May 20, 2025
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Reason: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Susceptibility Test Powders, AntimycobacterialDistribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE, BN, BR, CA, CN, CR, DO, GT, HK, HT, ID, IN, JP, KH, KR, MO, MX, MY, NP, NZ, PE, PH, PK, SG, SV, TH, TW, VN.Recall #Z-2023-2025
Open, ClassifiedPosted Jun 25, 2025·Initiated May 19, 2025
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Root cause: Process design
Recalling firm: Limacorporate S.p.AType: Shoulder Prosthesis, Reverse ConfigurationDistribution: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.Recall #Z-2024-2025
Open, ClassifiedPosted Jun 25, 2025·Initiated May 19, 2025
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Root cause: Process design
Recalling firm: Limacorporate S.p.AType: Shoulder Prosthesis, Reverse ConfigurationDistribution: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.Recall #Z-2025-2025
Open, ClassifiedPosted Jun 25, 2025·Initiated May 22, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Reason: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Root cause: No Marketing Application
Recalling firm: Jewel Precision Sheet Metal & Machining Co, Inc.Type: Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesDistribution: US Nationwide distribution in the states of IN, NY, PA.Recall #Z-2026-2025
Open, ClassifiedPosted Jun 25, 2025·Initiated May 22, 2025
Product: Atellica CH Diluent - CONS 2 x 1.5L;
Siemens Material Number (SMN): 11099300;
Reason: Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.Recall #Z-2027-2025