Recall Z-1416-2022 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
| Date | Jun 24, 2022 |
| Status | Open, Classified |
| Reason | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. |
| Quantity | 70 mattresses |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.