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U.S. Department of Health and Human Services

Class 2 Device Recall Pro 2000

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 Class 2 Device Recall Pro 2000see related information
Date Initiated by FirmOctober 09, 2008
Date PostedJanuary 07, 2009
Recall Status1 Terminated 3 on December 10, 2009
Recall NumberZ-0603-2009
Recall Event ID 50144
Product Classification Alternating Pressure Air Flotation Mattress - Product Code FNM
ProductPro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information ContactJoe Fogel
843-740-8586
Manufacturer Reason
for Recall		These devices have the potential to overheat.
FDA Determined
Cause 2		Device Design
ActionAll end users (those who either purchased the device and any customer that has rented) were notified by an Urgent Field Safety Notice on/about 10/31/2008. The letter informed the customers of the safety risk and list steps they can take to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that were sold, the consignee of each device was notified by letter for the safety risk and what they can do to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that are rented, an internal notification was sent via e-mail to Service Centers (Because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the Consignee). Each Service Center will perform the correction on the units affected.
Quantity in Commerce2,083 units (Total all four units)
DistributionNationwide Distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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