GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
FDA device recall Z-1713-2008 · posted 2008-09-30 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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, Ge
- Date initiated
- 2007-03-29
- Date posted
- 2008-09-30
- Date terminated
- 2012-02-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |