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U.S. Department of Health and Human Services

Class 2 Device Recall ALM SURGICAL LAMPS

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 Class 2 Device Recall ALM SURGICAL LAMPSsee related information
Date Initiated by FirmFebruary 23, 2009
Date PostedApril 12, 2009
Recall Status1 Terminated 3 on September 29, 2009
Recall NumberZ-1153-2009
Recall Event ID 51297
510(K)NumberK882613 
Product Classification Lamp, surgical - Product Code FTD
ProductALM Prismatic Surgical Light 9551 DF; 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: 567014999; Serial Numbers: 1104, 1105, 1106, 25163, 25340, 25341, 25890, 26012, 26417, 26418, 26686, 27251, 27753, 27854, 27855, 28096, 28097, 28813, 29652, 29950, 30087, 30152, 30333-30334, 30739, 31250, 31381, 32333, 32334, 32336, 32580, 32708, 32709 and 32800.
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22 East
Suite 202
Bridgewater NJ 08807-2958
For Additional Information ContactJamie 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		Device Design
ActionAn "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 Commerce54 of all units, both article numbers
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.
510(K) Database510(K)s with Product Code = FTD
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