Recall Z-0231-2023 ยท FNL Bed, Ac-Powered Adjustable Hospital
Baxter Healthcare Corporation
Hill-Rom Progressa Bed System
| Date | Nov 14, 2022 (initiated Oct 18, 2022) |
| Status | Open, Classified |
| Reason | The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed. |
| Root cause | Under Investigation by firm |
| Action | Baxter/Hill-Rom disseminated an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 10/18/2022 by UPS Ground Service. The notice explained the issue and potential risk and requested the following: "Actions to be taken by Customer: " Please identify if you have the impacted beds per Appendix A in your facility and remove from service immediately. Serial number can be found on the patient right side of the bed under the head rail. Return the enclosed response form within two weeks, confirming serial numbers of impacted beds in your facility. Action to be taken by the Distributor: " Ple |
| Quantity | 248 beds (Updated) |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, IN, LA, MA, MO, NC, NM, NV, NY, OK, OR, PA, SC. TN, TX, WA, and WI. (UPDATED: States of PA and SC and there was government distribution.) There was no military distribution. Foreign distribution was made to Canada, Qatar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.