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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnost

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 Class 2 Device Recall Diagnostsee related information
Date Initiated by FirmAugust 10, 2003
Date PostedSeptember 11, 2003
Recall Status1 Terminated 3 on January 13, 2005
Recall NumberZ-1212-03
Recall Event ID 27013
510(K)NumberK912470 
Product Classification Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
ProductDiagnost 96
Code Information Part Number: 9804 405 80001, 9804 405 80101, 9896 000 1284, 9896 000 12851, 9896 000 12451, 9896 000 1262, 9896 000 59041  The firm utilizes a site number specific to each unit: 6993, 62309, 25710, 25901, 62279, 13709, 62635, 76345, 41372, 31000, 17197, 25900, 62300, X0668, 13444, 6981, 6559, 6426, 6583, 38530, 6852, 683, 25907, 44760, 44670, 17368, 17325, 25769, 13951, 13608, 17247, 38507, 26018, 62278, 62391, 17304, 46921, 45014, 45013, 67642, 62404 37859, 86113, 38023, 6541, 74057, 74056, 61667, 62666, 62403, 62310, 35366, 50135, 13971, 25768, 62988, 62885, 38897, 6558, 44699, 76449, 25967, 25884, 25834, 44742, 6935, 40940, 62363, 62362, 38500, X1207, 6539, X1069, 6616, 17436, 59633, 52354, 47166, 17605, 17339, 62504, 62937, 62936, 59497
FEI Number 1000524572
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		Potential for table to move by itself
FDA Determined
Cause 2		Other
ActionThe firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade.
Quantity in Commerce54
DistributionThe firm distributed devices to hospitals and medical centers located throughout the U.S.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZZ
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