Z-2970-2018Class I

DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal...

Name: Z-2970-2018 DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal...
Creator: Pro-Med Instruments Gmbh
Published: 2018-07-05
License: https://open.fda.gov/license/

Black Forest Medical GmbH / initiated 2018-07-05 / Terminated / root cause: design

FDA source

Pro-Med Instruments Gmbh began a recall of DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries on 2018-07-05. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2970-2018
Classification: Class I
Status: Terminated
Initiated: 2018-07-05
Posted: 2018-09-17
Terminated: 2020-11-19
Recalling firm: Black Forest Medical GmbH
Product: DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
Root cause tag: design
FDA root cause: Component change control
Action: 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
Quantity in commerce: 30 units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2970-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2970-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17
Z-2971-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17
Z-2972-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17

Product code HBL

K032331Class IIDoro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)Pro-Med Instruments GmbH / cleared 2003-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)