Data Foundry

Medical device recalls 2018

DORO LUCENT Transitional Member — Class I medical device recall Z-2972-2018

Terminated recall by Pro-Med Instruments Gmbh, reported 2018-09-26, distributed in CA, GA, MS, OH, TN, TX, WV. The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and T

Recall numberZ-2972-2018
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPro-Med Instruments Gmbh, Freiburg Im Breisgau, N/A, Germany
Recall initiated2018-07-05
Classified2018-09-17
Reported by FDA2018-09-26
Terminated2020-11-19
DistributedCA, GA, MS, OH, TN, TX, WV
Countries outside the USAU, DE, GB, IN, IT, JP, QA, SG, ZA
Quantity31 units
Reason classesdevice malfunction
Serial numbers1704002, 1704004, 1704005, 1704006, 1704007, 1704008, 1704010, 1704011, 1704012, 1704014, 1704016, 1704017, 1704018, 1704019, 1704021, 1704024, 1704025, 1704026, 1704027, 1704028, 1704029, 1704030, 1704031, 1704032, 1704034 and 6 more
Model numbers1101.026

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2972-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.