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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Digital Diagnost VE

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  Class 2 Device Recall Philips Digital Diagnost VE see related information
Date Initiated by Firm November 20, 2003
Date Posted December 24, 2003
Recall Status1 Terminated 3 on January 13, 2005
Recall Number Z-0270-04
Recall Event ID 27839
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Digital Diagnost VE
Code Information Site numbers: 82652, 82681, 82723, 82730, 83073, 85495, 85696, 85697, 85698, 86222, 86382, 86383, 86987, 86988, 100572, 100806, 101933, 102030, 102100, 102115, 102116, 102117, 102489, 102539, 102596, 102713, 102717, 102719, 102787, 102905, 103109, 103165, 103262, 103271, 103272, 103436, 103437, 103438, 103439, 103453, 103511, 103778, 103893, 103894, 103953, 103971, 103976, 104014, 104338, 104465, 104578, 104673, 104676, 104864, 104902, 104903, 104904, 104937, 104938, 105158, 105198, 105199, 105322, 105367, 105415, X1641, X1642, X1650, X1767, X1768. The firm uses site numbers instead of serial numbers. 
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		 The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
FDA Determined
Cause 2		 Other
Action The firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004.
Quantity in Commerce 70 devices total
Distribution The firm distributed to medical facilities nationwide.
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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