Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The prod
FDA device recall Z-0400-2016 · posted 2015-12-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
- Action taken
- Philips Medical Systems sent a product safety notice to customers and corrective software for the issue was released to the field on July 25, 2006. Service Reps will contact each customer to install the new version of software. For questions regarding this recall call 440-483-7600.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 54 units
- Distribution
- Worldwide distribution, including US states of CA and NV.
- Date initiated
- 2006-04-25
- Date posted
- 2015-12-10
- Date terminated
- 2015-12-15
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357) | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 |