| Class 2 Device Recall OmniDiagnost |  |
Date Initiated by Firm | July 17, 2003 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number | Z-0874-03 |
Recall Event ID |
26837 |
510(K)Number | K982993 |
Product | OmniDiagnost System |
Code Information |
OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161; The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857 |
Recalling Firm/ Manufacturer |
Philips Medical Systems Sales & Service Region No. America 22100 Bothell Everett Highway Bothell WA 98041
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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 |
Action | On 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 Commerce | 52 |
Distribution | The firm distributed devices to 81 hospitals and medical centers located throughout the U.S. |
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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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510(K) Database | 510(K)s with Product Code =
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