Recall Z-2219-2009 ยท KPS System, Tomography, Computed, Emission
GE Medical Systems, LLC
GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.
| Date | Sep 17, 2009 (initiated Nov 3, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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). |
| Quantity | 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 CANADA, DENMARK, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHER |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051855 | VENTRI Ge Medical Systems F.I. Haifa, Aug 2, 2005 |