# FDA recall Z-1622-2023

> **PHILIPS HEADQUARTERS CAMBRIDGE** · Class II · device recall initiated 2023-04-12.

## Product

Incisive CT- whole-body computed tomography (CT) X-Ray System  Model Number: 728144

## 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

## 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

## Key facts

- **Recall number:** Z-1622-2023
- **Recalling firm:** PHILIPS HEADQUARTERS CAMBRIDGE
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-12
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1622-2023

## Citation

> AI Analytics. FDA recall Z-1622-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1622-2023. Source: US FDA. Licensed CC0.

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