Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
FDA device recall Z-2205-2015 · posted 2015-07-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
- Action taken
- On 6/4/2015, the firm mailed Customer Information Letters.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 66 units
- Distribution
- Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY,
- Date initiated
- 2015-03-17
- Date posted
- 2015-07-22
- Date terminated
- 2018-06-26
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |