Z-0404-2020 Class II Terminated
FDA device recall Z-0404-2020 was initiated by Galil Medical, Inc. on October 25, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 16, 2020). Affected quantity: 49 systems.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 25, 2019
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 systems
Product Description
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 touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
Reason for Recall
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 Pattern
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
Code Information
System Serial Number / PM Kit #: VL0031 / PM0506M, VL0036 / PM0546M, VL0067 / PM0515M, VL0069 / PM0565M, VL0075 / PM0532M, VL0079 / PM0539M, VL0082 / PM0491M, VL0085 / PM0486M, VL0086 / PM0499M, VL0088 / PM0489M, VL0090 / PM0513M, VL0092 / PM0548M, VL0093 / PM0544M, VL0094 / PM0520M, VL0100 / PM0516M, VL0102 / PM0529M, VL0105 / PM0560M, VL0112 / PM0542M, VL0115 / PM0525M, VL0136 / PM0561M, VL0148 / PM0514M, VL0153 / PM0531M, VL0171 / PM0564M, VL0175 / PM0559M, VL0181 / PM0512M, VL0186 / PM0533M, VL0191 / PM0492M, VL0220 / PM0545M, VL0230 / PM0528M, VL0238 / PM0500M, VL0249 / PM0498M, VL0271 / PM0497M, VL0275 / PM0543M, VL0280 / PM0549M, VL0283 / PM0488M, VL0285 / PM0566M, VL0287 / PM0562M, VL0291 / PM0524M, VL0300 / PM0550M, VL0301 / PM0541M, VL0303 / PM0530M, VL0304 / PM0563M, VL0308 / PM0523M, VL0309 / PM0507M, VL0310 / PM0490M, VL0311 / PM0555M, VL0312 / PM0526M, VL0321 / PM0552M, VL0362 / PM0527M.