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U.S. Department of Health and Human Services

Class 2 Device Recall Mechatronic Vario Guide

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  Class 2 Device Recall Mechatronic Vario Guide see related information
Date Initiated by Firm August 20, 2020
Create Date August 29, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-2925-2020
Recall Event ID 86272
510(K)Number K183605  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Code Information Article Number: 56000-01B, Description: CIRQ ARM SYSTEM 1.3.2,  Serial numbers:  20100132017  20100132019 20100132020 20100132022 20100132023 20100132026 20100132028 20100132030 20100132031 20100132033 20100132035 20100132036 20100132037 20100132038 20100132039   Article Number: 56000-01C, Description:CIRQ ARM SYSTEM 1.4,  Serial numbers:  20100140052  20100140053 20100140054 20100140055 20100140056 20100140057 
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall		 Holding force of the Positioning Arm can be reduced by prolonged non-use.
FDA Determined
Cause 2		 Component design/selection
Action Brainlab will be distributing the Medineering Field Safety Notice / Product Notification CAPA-17 to the consignees via email. Instruction for user on how to effectively avoid the situation of risk to occur (i.e. how to avoid the described potential risk), please also refer to the Corrective action by the user section of the Medineering Field Safety Notice / Product Notification CAPA-17. 1. Please identify all Positioning Arms with the specified serial numbers 2. Especially when the arm is freestanding and unsupported, ensure that the Positioning Arm is not above the patient or the user. 3. Avoid unfavorable positions of the Positioning Arm. Examples of these can be found in the instructions or use in the payload test section. 4. Check the secure hold after each arm alignment.
Quantity in Commerce 21 arms
Distribution USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
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 = OLO and Original Applicant = Brainlab AG
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