# FDA recall Z-2972-2018

> **Pro-Med Instruments Gmbh** · Class I · device recall initiated 2018-07-05.

## Product

DORO LUCENT Transitional Member, REF 1101.026   Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

## Reason for recall

The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.

## Distribution

Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan

## Key facts

- **Recall number:** Z-2972-2018
- **Recalling firm:** Pro-Med Instruments Gmbh
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-05
- **Report date:** 2018-09-26
- **Termination date:** 2020-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2972-2018

## Citation

> AI Analytics. FDA recall Z-2972-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2972-2018. Source: US FDA. Licensed CC0.

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