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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Device Recall Philipssee related information
Date Initiated by FirmJune 27, 2003
Date PostedAugust 12, 2003
Recall Status1 Terminated 3 on January 12, 2005
Recall NumberZ-1125-03
Recall Event ID 26514
510(K)NumberK983447 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductEasy Access Software releases 1.1, 5.2, 6.2 & 7.2
Code Information The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
FDA Determined
Cause 2		Other
ActionOn 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.
Quantity in Commerce46 devices
DistributionDevices were distributed to 23 hospitals and medical centers throughout the US.
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 = LLZ
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