Recall Z-1623-2023— PHILIPS HEADQUARTERS CAMBRIDGE
Class II · Ongoing
Class II FDA medical device recall by PHILIPS HEADQUARTERS CAMBRIDGE, initiated 2023-04-12. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS). Reason: 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.
- Recalling firm
- PHILIPS HEADQUARTERS CAMBRIDGE
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-12
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (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
Data sourced from openFDA. This site is unofficial and independent of the FDA.