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U.S. Department of Health and Human Services

Class 2 Device Recall Cirq Arm System 2.0

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 Class 2 Device Recall Cirq Arm System 2.0see related information
Date Initiated by FirmMarch 02, 2023
Date PostedMarch 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1292-2023
Recall Event ID 91781
510(K)NumberK222966 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductCirq Arm System 2.0
Code Information 56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.
FEI Number 3002619595
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall		Risk of mechanical instability due to potential manufacturing error of the device
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm issued a URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION to their consignees by email on 03/02/2023. The notice explained the issue, risk of use, and requested the following actions be taken: "1. Do not use Cirq Arm System 2.0 for clinical procedures. 2. Remove Cirq Arm System 2.0 from the OR table (as applicable), following the description given in the applicable User Guide. When lifting Cirq Arm System 2.0, ensure you carry the device only below joint 4 (see picture 1) to prevent user injury from falling parts. 3. Store the device in the corresponding transport and storage case delivered with it and ensure you mark the equipment appropriately to prevent it from being used inadvertently." Brainlab is seeking return of the devices for inspection and repair (if applicable).
Quantity in Commerce1 unit
DistributionTexas
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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