—#203580

Product

HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974

FDA product code: IOQ — Bed, Flotation Therapy, Powered
Device class: Class 2
Medical specialty: Physical Medicine
510(k) numbers: K122473
Affected lot / code info: UDI/DI 00887761966925, all serial numbers

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA

Timeline

Recall initiated: 2023-10-04
Posted by FDA: 2023-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.