Hill-Rom Progressa Bed System
Recall
- Recall Number
- Z-0231-2023
- Event Number
- 90990
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FNL
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 18, 2022
- Posted
- November 14, 2022
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Hill-Rom Progressa Bed System
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.
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: " Please share this Medical Device Correction Notice with your end users. " Complete response form and return to [email protected] within two weeks, identifying serial numbers of beds to be reworked. Hillrom will arrange shipment of replacement kit and associated instructions." "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or [email protected]" Update: On 11/22/2022 (and some on 12/12/2022), the firm issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to additional consignees via UPS Ground Service which provided the same instructions as the initial notification but added 59 additional serial numbers in the Appendix of the notification.
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, Singapore, and UAE. UPDATE: Saudi Arabia now included.
248 beds (Updated)