The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the bo
FDA device recall Z-1688-2012 · posted 2012-05-30 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
- Action taken
- Philips Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated May 8, 2012 to all affected customers. The letter identifies the product and problem. No action is required by the customers. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Philips Healthcare will inspect the cooling units on all iCT and iCT SP systems for this issue and if the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 372
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VT, WA and WV and the co
- Date initiated
- 2012-05-07
- Date posted
- 2012-05-30
- Date terminated
- 2013-02-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |