Cambridge, MA, United States
PHILIPS HEADQUARTERS CAMBRIDGE recalls
1 recall recorded since 2018, most recently on 12 April 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 April 2023
- 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
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1622-2023, Z-1623-2023, Z-1625-2023, Z-1624-2023
- Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
- Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
- Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
- Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.