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U.S. Department of Health and Human Services

Class 2 Device Recall Handy Laser Compact Laser centering

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  Class 2 Device Recall Handy Laser Compact Laser centering see related information
Date Initiated by Firm November 10, 2014
Date Posted August 13, 2015
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-2320-2015
Recall Event ID 69849
Product Classification System, x-ray, tomography, computed - Product Code RER
Product GE Optional Laser Centering Device X-ray generator.
Code Information Model No. 025.03.00A
Recalling Firm/
Manufacturer		 GE Inspection Technologies, LP
50 Industrial Park Rd
Lewistown PA 17044-9312
For Additional Information Contact
717-447-1278
Manufacturer Reason
for Recall		 GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.
Quantity in Commerce 25
Distribution US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
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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