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U.S. Department of Health and Human Services

Class 2 Device Recall MD 4

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  Class 2 Device Recall MD 4 see related information
Date Initiated by Firm April 06, 2006
Date Posted May 06, 2006
Recall Status1 Terminated 3 on May 21, 2008
Recall Number Z-0852-06
Recall Event ID 35177
510(K)Number K961374  
Product Classification X Ray System - Product Code JAA
Product MD4 X-ray system
Code Information Site numbers 102550 (20279385), 103023, 38783, 102562 (20279430), 83957, 101155, 82628, 38442, 83038, 13721, 85034, 102583, 80306, 41156, 38993, 84930, X1321, 41032, X1077, 100014, 50328, 17656, 83367, 38586, 100954, 76834, 87176, 41426, 104137, 82800, 103651, 10388, 41111, 17622, 13918, 103377, 101038, X0934, 102034, 52471, 76804, 50251, 44898, 13258, 86545, 101863, 38587, 103043 (20283876), 82688, 38635, 47160, 14099, 45042, 38917, 101156 (20278521), 86328, 38501, 13879, 41439, 41069, 76975, X1277, 100637, X1078, 35484, 101759, 84463, 105022, X1751, 76877, 13172, 38944, 41143, 85694, 87140, 59546, 13704, 10458, 45039, 76869, 52455, 84892, 41271, 87302, 6842, 41031, 41000, X0662, 87030, 76808, 6838, 62938, 86218, 85491, 50340, 82687, 38912, 101153, 103210
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Potential for unexpected table movement.
FDA Determined
Cause 2		 Other
Action On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
Quantity in Commerce 100 units
Distribution Units were distributed to hospitals and medical centers located throughou the US.
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.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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