Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
This recall has been terminated (originally issued August 19, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- August 19, 2014
- Terminated
- June 14, 2016
- Recall Number
- Z-0364-2016
- Quantity
- 1517 systems, not all units have the patient support accessory
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Distribution
Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Lot / Code Info
All patient support for stitching are affected.
Root Cause
Device Design
Action Taken
The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.