Stryker 2030 Epic and Plus Critical Care Bed

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Ambulance / transport vehicles
• Emergency Department
• Inter-facility transport teams

Documents & Manuals

• Epic and Plus Operations Manual.pdfUser Manual · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

• RECALL

  The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.

• RECALL

  Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.

• RECALL

  The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

• RECALL

  CPU board failures cause fowler (backrest) electronic controls to stop working.

• RECALL

  Potential for power cord to melt; hazards include electric shock and fire.

• RECALL

  It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached

• RECALL

  Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.

• RECALL

  It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

• RECALL

  Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

• RECALL

  The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.

• RECALL

  Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.

• RECALL

  Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

• RECALL

  Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

• RECALL

  An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

• RECALL

  Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

• RECALL

  Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.

• RECALL

  Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.

• RECALL

  The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.

• RECALL

  Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.

• RECALL

  The backrest of the bed may not stay in an upright position (may drift down when left raised).

• RECALL

  Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.

• RECALL

  Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

• RECALL

  Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

• RECALL

  The brakes may not have adequate holding power to lock the bed in place.

• RECALL

  Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

• RECALL

  The bed exit may not alarm as appropriate.

• RECALL

  Trendelenburg and reverse trendelenburg features may not function.

• RECALL

  A wire may break at the crimp and present a potential electric shock hazard.