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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 Progressa see related information
Date Initiated by Firm October 04, 2023
Date Posted November 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0212-2024
Recall Event ID 93161
510(K)Number K122473  
Product Classification Bed, flotation therapy, powered - Product Code IOQ
Product HILLROM 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
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center 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
Action 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.
Quantity in Commerce 499 beds
Distribution US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IOQ and Original Applicant = HILL-ROM
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