Date Initiated by Firm | October 07, 2009 |
Date Posted | November 12, 2009 |
Recall Status1 |
Terminated 3 on June 04, 2012 |
Recall Number | Z-0186-2010 |
Recall Event ID |
53499 |
510(K)Number | K040735 |
Product Classification |
Surgical Ceiling Mounted Light - Product Code FSY
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Product | XTEN DF cupola, P/N: 567800999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. |
Code Information |
Part Number: 567800999 |
Recalling Firm/ Manufacturer |
MAQUET Inc. 1140 Us Highway 22 Ste 202 Bridgewater NJ 08807-2958
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For Additional Information Contact | Jamie Yieh 732-667-1896 |
Manufacturer Reason for Recall | Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. |
FDA Determined Cause 2 | Device Design |
Action | Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative. |
Quantity in Commerce | 54 |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FSY
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