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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnost 97

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 Class 2 Device Recall Diagnost 97see related information
Date Initiated by FirmJuly 17, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 12, 2005
Recall NumberZ-1242-03
Recall Event ID 26837
510(K)NumberK912470 
ProductDiagnost 97
Code Information Diagnost 97 system code 708023, 70852, 70853, 70855, 70859. The firm utilizes a ''site number'' specific to each unit:   13608, 17605, 37995, 38897, 40940, 47166, 59633, 62936, 62937, 6935, 6981, 74057, 13709, 17436, 35481, 59497, 62885, 74056, 76345, 13951, 13971, 38500, 38530, 38657, 41372, 45013, 45014, 62988, 6993, X0668, X1069, X1207, 6852, 62504, 38023, 62666, 62667, 6853  
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		Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
FDA Determined
Cause 2		Other
ActionOn 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
Quantity in Commerce38
DistributionThe firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
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 =
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