FDA Medical Device Recalls (openFDA)
Pro-Med Instruments Gmbh: DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
- Recall number
- Z-2970-2018
- Recalling firm
- Pro-Med Instruments Gmbh
- Product
- DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
- Status
- Terminated
- Initiated
- 2018-07-05
- Posted
- 2018-09-17
- Terminated
- 2020-11-19
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032331"]
- PMA numbers
- not on file
- Product code
- HBL
- Firm FEI
- 3003923584
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28