Recall StatusTerminated
Date Initiated2019-03-29
Date Terminated2021-04-15
Product Quantity825 (38 US and 787 OUS) in total
Reason for Recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Firm Action
On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers
were instructed to do the following:
Please follow the precautions below until the monitor feet on your unit are replaced:
-The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use.
-Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative.
-Monitor should not be positioned directly above the patient.
-Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures.
Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to:
[email protected]. F/U visits by GE Healthcare will be made to replace the plastic feet.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
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.