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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Progressa

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 Class 2 Device Recall HillRom Progressasee related information
Date Initiated by FirmOctober 04, 2023
Date PostedNovember 02, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0212-2024
Recall Event ID 93161
510(K)NumberK122473 
Product Classification Bed, flotation therapy, powered - Product Code IOQ
ProductHILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
Code Information UDI/DI 00887761966925, all serial numbers
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionBaxter 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.
Quantity in Commerce499 beds
DistributionUS Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IOQ
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