IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reported: March 14, 2018 Initiated: January 11, 2018 #Z-0841-2018
Product Description
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reason for Recall
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 63
- Distribution
- Domestic and Foreign
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 63.
Why was this product recalled? ▼
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0841-2018.
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