Recalls / —
—#84486
Product
LithoDiagnost
- FDA product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Device class
- Class 2
- Medical specialty
- Radiology
- Affected lot / code info
- N/A
Why it was recalled
The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
Root cause (FDA determination)
Radiation Control for Health and Safety Act
Action the firm took
A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.
Recalling firm
- Firm
- Philips Medical Systems North America Co. Phillips
- Address
- 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431
Distribution
- Distribution pattern
- Worldwide Distribution
Timeline
- Recall initiated
- 2009-07-06
- Posted by FDA
- 2009-09-24
- Terminated
- 2011-12-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #84486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.