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U.S. Department of Health and Human Services

Class 2 Device Recall Lamp, surgical

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 Class 2 Recall
Lamp, surgical
see related information
Date Posted April 12, 2009
Recall Status1 Terminated on September 29, 2009
Recall Number Z-1154-2009
Recall Event ID 51297
Premarket Notification
510(K) Number
K882613 
Product Classification Lamp, Surgical - Product Code FTD
Product Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
Code Information Article Number: 567030999; Serial Numbers: 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6057, 6058, 6059, 6060, 6061 and 6062.
Recalling Firm/
Manufacturer
MAQUET Inc.
1140 US Highway 22 East
Suite 202
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1896
Manufacturer Reason
for Recall
The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
FDA Determined
Cause 2
DESIGN: Device Design
Action An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.
Quantity in Commerce 54 of all units, both article numbers
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = ALM SURGICAL EQUIPMENT, INC.
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