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Terminated

GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.

FDA Recall Z-0897-06 · Posted 2006-05-24

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMQB
Date Initiated2006-03-06
Date Terminated2008-02-24
Product Quantity300 (191 domestic and 109 OUS)

Reason for Recall

Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

Firm Action

GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.

Root Cause

Other

Distribution Pattern

Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031637INNOVA 3100GE Medical Systems · 2003-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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