Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners ar
FDA device recall Z-1646-2013 · posted 2013-07-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
- Action taken
- Philips Healthcare sent an Urgent Medical device Correction letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to resolve the issue and a Philips Field Service Engineer will contact each site to schedule the software installation. For questions contact your local Philips representative or local Philips Healthcare office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.
- Distribution
- USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, P
- Date initiated
- 2013-04-15
- Date posted
- 2013-07-02
- Date terminated
- 2015-01-12
- 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 |