GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
FDA Recall Z-2731-2016 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2016-08-31
Date Terminated2018-07-31
Product Quantity383 (US = 24;OUS = 359)
Reason for Recall
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Firm Action
Consignees were sent on 8/31/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 67921 dated August 31, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists.
The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Root Cause
Software design
Distribution Pattern
US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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