Recalls / —
—#141095
Product
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
- FDA product code
- KPR — System, X-Ray, Stationary
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K031535
- Affected lot / code info
- All patient support for stitching are affected.
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Philips Medical Systems, Inc.
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2014-08-19
- Terminated
- 2016-06-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #141095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.