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.
FDA Recall Z-0029-2020 · Posted None
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeMQG
Date Initiated2019-09-05
Date Terminated2021-09-02
Product Quantity60
Reason for Recall
The touchpad may not work properly after cleaning.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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