Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomogr
FDA device recall Z-2155-2011 · posted 2011-05-09 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.
- Action taken
- Customer information sheets will be provided to all customers when the field change order commences in April 2011. Philips will implement a full change order for the installation of the new headholder to replace the old headholder, free of charge, to all affected Philips BrightView XCT SPECT/CT units. For questions regarding this recall call 408-463-3000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 49
- Distribution
- Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indone
- Date initiated
- 2011-03-28
- Date posted
- 2011-05-09
- Date terminated
- 2011-06-22
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHTVIEW VCT IMAGING SYSTEM (K080927) | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 |