GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intende
FDA device recall Z-1094-2009 · posted 2009-04-10 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.
- Action taken
- Consignees were sent from September 2008 - Feb 2009 a GE "Product Safety Notification" letter dated 4/2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. It instructed consignees to continue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service reps should be contacted for further information regarding the notification.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 153 US, 264 OUS
- Distribution
- Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, DC, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK ,OR, PA, PR, SD
- Date initiated
- 2008-09-08
- Date posted
- 2009-04-10
- Date terminated
- 2012-05-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE QUASAR NUCLEAR MEDICINE SYSTEM (K022960) | Ge Medical Systems F.I. Haifa | 2002-09-19 |