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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 17, 2005
Date Posted June 22, 2005
Recall Status1 Terminated 3 on November 17, 2005
Recall Number Z-0919-05
Recall Event ID 32093
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE.
Code Information Serial numbers 374061 through 374065, 374489 through 374519, 374521 through 374531, 375262, 376203 through 376211, 376229 through 376236, 376268 through 376284, 376698, 377647, 377648, 380181, 381593, 382244, 382373 through 382382, 383163 through 383166, 384390 through 384399, 386463 through 386468, 387057 through 387066, 387977 through 388004, 388039 through 388046, 388049 through 388063, 388153 through 388195, 388515 through 388527, 388529, 388679 through 388681, 388728 through 388735 and 389410 through 389414.
Recalling Firm/
Manufacturer		 Carroll Healthcare Inc.
1881 Huron St
London Canada N6E1P5
Ontario
For Additional Information Contact
519-659-4001
Manufacturer Reason
for Recall		 The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
FDA Determined
Cause 2		 Other
Action Consignees were sent a fax on 5/17/05 advising them of the problem and instructing them to lock-out the HILO pendant function on the attendant control pad until the firm visits their facility and corrects their beds.
Distribution Nationwide.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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