Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Sy
FDA device recall Z-2451-2012 · posted 2012-09-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
- Action taken
- Philips Healthcare sent an Urgent Medical Device Correction letter dated August 22, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that no action needed to be taken at that time b the customer or user. A Philips Field Service Engineer would schule a time to inspect and repair all the affected systems within approximately 6 months. For further information customers were instructed to contact their local Philips representative or contact the Philips Healthcare Customer Care Solution Center at 1-800-722-9377 and follow the recorded menu options toreach a Customer Solutions Engineer. For questions regarding this recall call 440-483-7000.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 112 Units
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, G
- Date initiated
- 2012-08-21
- Date posted
- 2012-09-25
- Date terminated
- 2013-12-24
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI IMAGING SYSTEM (K013521) | Adac Laboratories | 2001-11-07 |
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |