Date Initiated by Firm | November 21, 2002 |
Date Posted | September 12, 2003 |
Recall Status1 |
Terminated 3 on January 13, 2005 |
Recall Number | Z-1229-03 |
Recall Event ID |
26580 |
510(K)Number | K932645 |
Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
|
Product | Gyroscan Intera 1.0T & 1.5T |
Code Information |
Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x |
Recalling Firm/ Manufacturer |
Philips Medical Systems 22100 Bothell Everett Highway Bothell WA 98041
|
For Additional Information Contact | 425-487-7000 |
Manufacturer Reason for Recall | Patient burns from cables near or in contact with the patient during use |
FDA Determined Cause 2 | Other |
Action | On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual. |
Distribution | The firm distributed units to hospitals and medical centers throughout the U.S. |
Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = LNH
|