HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A00005
FDA device recall Z-0212-2024 · posted 2023-11-02 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.
- Action taken
- Baxter issued an Urgent Medical Device Correction notice to its consignees on 10/04/2023 by USPS first class mail. The notice explained the potential problem and hazard. Baxter will be correcting this issue by installing a conductive drag chain on the Progressa+ bed frame to prevent the electrostatic charge buildup. A Baxter representative will contact your facility to schedule a device correction to add the conductive drag chain. Please note you will be receiving this correction from Baxter at no charge. All units purchased in the future will have the drag chain.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- IOQ
- Quantity affected
- 499 beds
- Distribution
- US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
- Date initiated
- 2023-10-04
- Date posted
- 2023-11-02
- Location
- Deerfield, IL
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| TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 (K122473) | Hill-Rom | 2013-06-03 |