| Class 2 Device Recall Digital Diagnost, stationary radiographic system | |
Date Initiated by Firm | March 17, 2014 |
Date Posted | April 24, 2014 |
Recall Status1 |
Terminated 3 on September 16, 2020 |
Recall Number | Z-1503-2014 |
Recall Event ID |
67859 |
510(K)Number | K982795 |
Product Classification |
Solid stae x-ray (flat panel/digital imager) - Product Code MBQ
|
Product | Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 |
Code Information |
Units distributed from November 2006 through March 2014. |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue.
For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377 |
Quantity in Commerce | 985 devices |
Distribution | Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico |
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 = MBQ
|
|
|
|