Brainlab AG Olof-palme-str. 9 Munich Germany Cirq Arm System 2.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cirq Arm System 2.0
Brand
Brainlab AG Olof-palme-str. 9 Munich Germany
Lot Codes / Batch Numbers
56500 CIRQ ARM SYSTEM 2.0, GTIN 04056481143961, All available Serial numbers/lot numbers are affected.
Products Sold
56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.
Brainlab AG Olof-palme-str. 9 Munich Germany is recalling Cirq Arm System 2.0 due to Risk of mechanical instability due to potential manufacturing error of the device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Risk of mechanical instability due to potential manufacturing error of the device
Recommended Action
Per FDA guidance
The 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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX
Page updated: Jan 10, 2026