Recall Z-0029-2020 ยท MQG Accessory, Assisted Reproduction
CooperSurgical, Inc.
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 p
| Date | Sep 5, 2019 |
| Status | Terminated |
| Reason | The touchpad may not work properly after cleaning. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160504 | RI Witness Embryology Heated Plate Research Instruments Limited, Jul 18, 2016 |