GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use
FDA device recall Z-2219-2009 · posted 2009-09-17 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.
- Action taken
- GE Healthcare issued a "Product Safety Notification" dated January 2009 to consignees. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Field Engineer will visit each site and implement the correction. For further information, contact your local GE Healthcare service representative at 1-800-437-1171 (US or Canada) or 1-262-896-2890 (outside the US).
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 308 (252 US, 57 OUS)
- Distribution
- Worldwide Distribution -- US (AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MS, MO, NE, NV, NH, NJ, NY, NC, OH,OK PA, RI,SC, TN, TX, UT, VA, WA, WI and WV), AUSTRALIA, BRAZIL
- Date initiated
- 2008-11-03
- Date posted
- 2009-09-17
- Date terminated
- 2012-07-12
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTRI (K051855) | Ge Medical Systems F.I. Haifa | 2005-08-02 |