Date Initiated by Firm | June 08, 2004 |
Date Posted | August 04, 2004 |
Recall Status1 |
Terminated 3 on February 09, 2006 |
Recall Number | Z-1307-04 |
Recall Event ID |
29470 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
|
Product | MultiDiagnost Eleva
Part Numbers: 9896 001 41501 and 9896 001 41502 |
Code Information |
505039, 104530, 506247, 102666, 104136, 104838, 506155, 105194. |
Recalling Firm/ Manufacturer |
Philips Medical Systems Sales & Service Region No. America 22100 Bothell Everett Hwy Bothell WA 98021
|
For Additional Information Contact | Sarah Baxter 425-487-7665 |
Manufacturer Reason for Recall | When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination. |
FDA Determined Cause 2 | Other |
Action | The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2. |
Quantity in Commerce | 8 |
Distribution | Philips Medical Systems North American Company distributes product to medical facilities nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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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