Recall Z-1468-2025 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
| Date | Mar 26, 2025 (initiated Feb 25, 2025) |
| Status | Open, Classified |
| Reason | The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 2/25/25 was sent to customers. Actions to be Taken by Customers 1. Please locate all affected units within your facility by reviewing the product label at the head end of the Progressa bed surface with the affected product details provided above. Baxter recommends identifying patients at a higher risk for pressure injuries and placing these patients on alternate beds, if available. 2. A Baxter representative will contact your facility to schedule the correction of your impacted surfaces, or you may contact the Baxter Technical Su |
| Quantity | 2,126 units |
| Distribution | US Nationwide. Global Distribution. |
| 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 |