GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular
FDA device recall Z-1661-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Ge Healthcare, Llc
- Reason for recall
- A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.
- Action taken
- Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 92
- Distribution
- Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS,
- Date initiated
- 2010-03-24
- Date posted
- 2010-05-26
- Date terminated
- 2013-05-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163) | Ge Medical Systems, LLC | 2006-06-07 |
| INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ (K052412) | GE Healthcare | 2005-09-16 |
| INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157) | Ge Medical Systems, LLC | 2005-08-25 |
| INNOVA 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |