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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-0920-05
Recall Event ID 32093
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE.
Code Information Serial numbers 376078, 376079, 376155, 376156, 376219, 376220, 376223 through 376225, 376228, 376680 through 376683, 377067, 377262, 378422 through 378424, 378543 through 378552, 378698 through 378700, 378801 through 378806, 378811, 379168 through 379178, 379191, 379419 through 379421, 379472 through 379476, 379605 through 379611, 379719, 379720, 379831 through 379842, 379957 through 379959, 380047 through 380050, 380172 through 380180, 381130 through 381139, 381215, 381320 through 381326, 381416, 381589, 381590, 381595 through 381599, 381964, 381965, 382007 through 382010, 382167, 382168, 382171, 382172, 382283, 382422, 382764 through 383767, 383127, 383148, 383286 through 383288, 383484 through 383488, 383521, 383624, 383625, 383642, 383643, 383787, 383788, 384091 through 384100, 384225, 384226, 384480, 384727 through 384750, 384839, 384840, 385291 through 385297, 385752 through 385796, 385958, 386044 through 386063, 386327 through 386336, 386356 through 386361, 386366, 386412, 386435 through 386438, 386487 through 386492, 386511, 386530, 386570 through 386572, 386719 through 386724, 386733, 386746, 386776, 386926 through 386935, 386942, 386943, 387054 through 387056, 387495 through 387498, 387568, 387823, 388035 through 388038, 388207, 388468, 388542 through 388551, 388765 through 388771, 388796, 388877 through 388881, 389124, 389274, 389340 through 389389, 389417 through 389431 and 390437 through 390442.
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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