Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Reported: May 31, 2023 Initiated: April 12, 2023 #Z-1624-2023
Product Description
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Reason for Recall
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Details
- Recalling Firm
- PHILIPS HEADQUARTERS CAMBRIDGE
- Units Affected
- 1 unit
- Distribution
- AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS). Recalled by PHILIPS HEADQUARTERS CAMBRIDGE. Units affected: 1 unit.
Why was this product recalled? ▼
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1624-2023.
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