DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Recall Z-2970-2018 · Posted 2018-09-17
Recalling FirmPro-Med Instruments Gmbh
Recall StatusTerminated
Product CodeHBL
Date Initiated2018-07-05
Date Terminated2020-11-19
Product Quantity30 units
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.
Firm 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
Root Cause
Component change control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.