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Class 2 Device Recall Diagnost 97 |
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Date Initiated by Firm |
July 17, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number |
Z-1242-03 |
Recall Event ID |
26837 |
510(K)Number |
K912470
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Product |
Diagnost 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
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For Additional Information Contact |
425-487-7000
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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).
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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 |
38 |
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 = and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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