DORO LUCENT Base Unit, REF 1101.021 Headrest System used… recallZ-2970-2018 · Pro-Med Instruments Gmbh · initiated Jul 5, 2018
Class I Terminated All recalls posted in September 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pro-Med Instruments Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component change control
What the company is doing
The firm initiated the recall by email on 07/05/2018. This stage is only relevant for hospitals / users who are in possession with concerned products of two different revisions (mix-up): a) Discontinue the use of the combination and quarantine the concerned products b) Contact pro med instruments for further instructions relating to temporary replacement possibilities
Recall details
- Recall number
- Z-2970-2018
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jul 5, 2018
- Posted by the FDA
- Sep 17, 2018
- Recalling firm
- Pro-Med Instruments Gmbh
- Quantity
- 30 units
- Product code
- HBL
- FDA submissions
- K032331
- 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
Product description
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Code information (models, lots, serial numbers)
Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704019 1704012 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039
Other devices under the same FDA submission
1 device cleared under K032331 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DORO® Skull Clamp 4001-20Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80628).
- Z-2971-2018 · TerminatedDORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
- Z-2972-2018 · TerminatedDORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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