Recall
Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian…
Varian Medical Systems, Inc. Oncology Systems · 6 Oct 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.”
- Recall began
- 6 Oct 2011
- Company
- Varian Medical Systems, Inc. Oncology Systems
- Device type
- Product code (JAQ)
- Concerns
- K891131
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.