Recall Z-0212-2024 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
| Date | Nov 2, 2023 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 499 beds |
| Distribution | US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 Hill-Rom, Jun 3, 2013 |