Recall Z-1713-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
| Date | Sep 30, 2008 (initiated Mar 29, 2007) |
| Status | Terminated |
| Reason | The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008. |
| Quantity | 132 |
| Distribution | Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |