# FDA recall Z-1927-2018

> **GETINGE US SALES LLC** · Class II · device recall initiated 2017-11-16.

## Product

ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

## Reason for recall

Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.

## Distribution

U.S. and Gov. accts.

## Key facts

- **Recall number:** Z-1927-2018
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-16
- **Report date:** 2018-05-30
- **Termination date:** 2021-07-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2018

## Citation

> AI Analytics. FDA recall Z-1927-2018. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1927-2018. Source: US FDA. Licensed CC0.

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