Saint Paul, MN, United States
Galil Medical, Inc. recalls
1 recall recorded since 2018, most recently on 25 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 October 2019
- Terminated
- 16 September 2020
- Reason
- Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
- Distribution
- AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA, Puerto Rico OUS to include: Argentina, Canada, Taiwan, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0404-2020
- Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.