Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer
FDA device recall Z-2258-2015 · posted 2015-07-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
- Action taken
- On 2/5/2015 the firm sent Customer Information Letters to their customers.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 139 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and
- Date initiated
- 2015-02-05
- Date posted
- 2015-07-24
- Date terminated
- 2018-06-26
- 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 |