Recall
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)
Brainlab AG · 20 Aug 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “Holding force of the Positioning Arm can be reduced by prolonged non-use.”
- Recall began
- 20 Aug 2020
- Company
- Brainlab AG
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K183605
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.