GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
FDA device recall Z-1517-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 146 total
- Distribution
- Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia.
- Date initiated
- 2007-10-21
- Date posted
- 2008-09-29
- Date terminated
- 2011-12-17
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |