GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System).
FDA device recall Z-0914-2007 · posted 2007-06-09 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may impact patient or staff safely.
- Action taken
- Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 165
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU,
- Date initiated
- 2007-02-05
- Date posted
- 2007-06-09
- Date terminated
- 2011-12-17
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |