Recall Z-0212-2024— Baxter Healthcare Corporation

Name: FDA recall Z-0212-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-10-04. It names one FDA 510(k) clearance: K122473. Product: HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974. Reason: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-10-04
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-Rom·cleared 2013-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.