GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
FDA Recall Z-1516-2008 · Posted 2008-09-29
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMQB
Date Initiated2007-10-21
Date Terminated2011-12-17
Product Quantity146 total
Reason for Recall
Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a c
Firm Action
GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed at their site at no cost.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia.
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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