PlainRecalls
FDA Devices Low Class III Terminated

Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise

Reported: October 9, 2019 Initiated: September 5, 2019 #Z-0029-2020

Product Description

Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Reason for Recall

The touchpad may not work properly after cleaning.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
60
Distribution
Worldwide distribution - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ, PA, & WA, and countries of Canada and Denmark.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.. Recalled by CooperSurgical, Inc.. Units affected: 60.
Why was this product recalled?
The touchpad may not work properly after cleaning.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 9, 2019. Severity: Low. Recall number: Z-0029-2020.