Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Reported: April 23, 2014 Initiated: March 6, 2014 #Z-1464-2014
Product Description
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Reason for Recall
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 116 units
- Distribution
- Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 116 units.
Why was this product recalled? ▼
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1464-2014.
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