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.
Recall
- Recall Number
- Z-0029-2020
- Event Number
- 83108
- Firm
- CooperSurgical, Inc.
- FEI Number
- 1216677
- Product Code
- MQG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 5, 2019
- Terminated
- September 2, 2021
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350
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.
The touchpad may not work properly after cleaning.
On September 5, 2019, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers who identified affected product at their site were instructed to complete the customer acknowledgement form to arrange for an onsite field service call at CooperSurgical's expense. Otherwise, the issue will be addressed at the customer's next onsite routine service at no expense for the correction. Customers may direct their questions to the firm at 203-601-5200 ext. 3300.
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.
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