GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system i
FDA device recall Z-0367-2014 · posted 2013-11-20 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated September 25, 2013, to all affected customers. The letter identified the product the problem and the actions to be taken by the customer. We plan to correct all of the affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 systems that were distributed The plan for public warning is to contact all customers with an affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 system by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to 3 titles within the affected accounts; Managers of Nuclear Medicine, Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology. A GE Healthcare Field Engineer will perform the required software update on each affected system. Contact Information (GE Healthcare Call Center: USA or Canada 800-437-1171 and Other countries:( 262-896-2890).
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 464 (143 US, 321 OUS)
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC,
- Date initiated
- 2013-10-25
- Date posted
- 2013-11-20
- Date terminated
- 2014-04-01
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA NM/CT 640 (K121019) | GE Healthcare | 2012-04-19 |
| BRIVO NM 615 (K113350) | GE Healthcare | 2011-12-05 |
| DISCOVERY NM 630 (K111445) | GE Healthcare | 2011-06-03 |
| DISCOVERY MODEL NM/CT 670 (K093514) | Ge Medical Systems F.I. Haifa | 2009-12-10 |