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U.S. Department of Health and Human Services

Class 1 Device Recall DORO LUCENT Locking Transitional Member

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  Class 1 Device Recall DORO LUCENT Locking Transitional Member see related information
Date Initiated by Firm July 05, 2018
Date Posted September 17, 2018
Recall Status1 Terminated 3 on November 19, 2020
Recall Number Z-2971-2018
Recall Event ID 80628
510(K)Number K032331  
Product Classification Holder, head, neurosurgical (skull clamp) - Product Code HBL
Product DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Code Information Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704012 1704019 1704037 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039 1709014 
Recalling Firm/
Manufacturer		 Pro-Med Instruments Gmbh
Botzinger Str. 38
Freiburg Im Breisgau Germany
Manufacturer 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.
FDA Determined
Cause 2		 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 31 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBL and Original Applicant = PRO-MED INSTRUMENTS GMBH
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