Incisive CT Power- Whole-body computed tomography recall
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Why was Incisive CT Power- Whole-body computed tomography 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)00884838103467 (21) Serial Number: 102342065
- Product
- Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
- Recalling firm
- PHILIPS HEADQUARTERS CAMBRIDGE
- Quantity
- 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
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)