GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ASM001620 ASM500016 H3000WM H30
FDA device recall Z-1119-2009 · posted 2009-04-10 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
- Action taken
- Consignees were sent a GE "Product Safety Notification" letter dated April 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. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US).
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 365 US and 408 OUS
- Distribution
- Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, O
- Date initiated
- 2008-06-02
- 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 |