Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-se
FDA device recall Z-0409-2016 · posted 2015-12-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
- Action taken
- On March 3, 2011, the firm sent Field Service Notices to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1,765 units
- Distribution
- Worldwide Distribution. US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Re
- Date initiated
- 2011-03-03
- Date posted
- 2015-12-10
- Date terminated
- 2015-12-15
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |