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U.S. Department of Health and Human Services

Class 2 Device Recall VariCam

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  Class 2 Device Recall VariCam see related information
Date Initiated by Firm October 30, 2017
Create Date January 09, 2019
Recall Status1 Completed
Recall Number Z-0704-2019
Recall Event ID 81736
510(K)Number K953801  
Product Classification System, tomography, computed, emission - Product Code KPS
Product VariCam
Code Information Serial Numbers: 0000000010-203 0000000010-191 000003100-1829 00008125-18-18 00000000010-15 00000000010-63 00008125-16-59 000000099-4-04 00000000010-31 00000000010-82 00008125-16-70 00008125-18-09 00008125-18-16 00000000017-64 10280 00000000010-30 000003681-1803 00000000018-24 000003100-1840 000003101-1502 000003100-1744 00000000017-36 00000000016-86 00000000017-31 1065 1998 1999 000008125-1630 1008 00000000017-20 00000000017-22 00000000017-23 1804 00000000030-14 00000000030-15 00000000010-37 00000000010-44 00000000010-55 00000000030-16 00000000018-39 1704 00000ICPO50612 1697 1696 000000163-1758 00000000018-23 00000000016-73 00000000030-04 00000000010-59 00000000018-22 000003100-1760 000003100-1743 0000000010-134 000003100-1719 343 000003100-1763 61061 00000000010-04 00000000030-11 1649 00000000010-67 00000000010-45 00000000017-27 00000000017-15 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.
FDA Determined
Cause 2		 Other
Action The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products.
Quantity in Commerce 64 units
Distribution Worldwide
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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ELSCINT, INC.
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