Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to p
FDA device recall Z-1168-2013 · posted 2013-04-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
- Action taken
- Consignees were sent on 1/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated January 9, 2013. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology / Head of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 556
- Distribution
- Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA
- Date initiated
- 2013-01-09
- Date posted
- 2013-04-24
- Date terminated
- 2013-08-06
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTRI 1.1 (K080124) | Ge Medical Systems F.I. Haifa | 2008-01-31 |
| VENTRI (K051855) | Ge Medical Systems F.I. Haifa | 2005-08-02 |