Recall Z-2307-2021 · FMZ Incubator, Neonatal

CooperSurgical, Inc.

Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Wo

Date	Jun 30, 2021
Status	Terminated
Reason	Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.
Root cause	Vendor change control
Action	CooperSurgical notified affected affected Regionals and Countries and through the Sales Managers to Affected Consignees by Urgent Field Safety Notice Oxygen Sensors letter via email on 6/30/21. Letter states reason for recall, health risk and action to take: If the affected product at your facility is displaying any of the above characteristics, please complete the attached Acknowledgement and Receipt Form to arrange for an onsite field service call at CooperSurgicals expense. Otherwise, this issue will be addressed at your next onsite routine service at no expense for the correction. Pl
Quantity	421 units
Distribution	Only Foreign: Bahrain, Belgium, Bulgaria, Czech Republic Denmark, Egypt, Estonia, France, Georgia, Germany, Ghana, Great Britain, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore,
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.