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HILLROM PROGRESSA+ BED, Product Codes: P7501A000016… recallZ-0212-2024 · Baxter Healthcare Corporation · initiated Oct 4, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0212-2024
Status
Open, Classified
Initiated by the company
Oct 4, 2023
Posted by the FDA
Nov 2, 2023
Recalling firm
Baxter Healthcare Corporation
Quantity
499 beds
Product code
IOQ
FDA submissions
K122473
Distribution
US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00887761966925, all serial numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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