# FDA recall Z-1383-2023

> **Philips North America Llc** · Class II · device recall initiated 2023-03-09.

## Product

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy  Model Number :  712204

## Reason for recall

If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through  normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

## Distribution

Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen

## Key facts

- **Recall number:** Z-1383-2023
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-09
- **Report date:** 2023-04-19

- **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-1383-2023

## Citation

> AI Analytics. FDA recall Z-1383-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1383-2023. Source: US FDA. Licensed CC0.

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