CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies recalled
GE OEC Medical Systems is recalling GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (, distributed in Maryland, Montana, North Carolina, New Jersey, New York, Utah. The recall was initiated on 22 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1638-2015
- FDA event ID
- 71298
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2014
- FDA classified
- 8 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 22 May 2014 | Recall initiated by company | |
| 8 Jun 2015 | Classified by FDA | +382 days |
| 17 Jun 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
Product as listed by the FDA
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Where it was distributed
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
Questions about this recall
Why was it recalled?
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
Which lots are affected?
OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
Where was it sold?
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE OEC Medical Systems
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide |
Other Imaging Equipment recalls
All 2,341| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips EPIQ Elite Diagnostic Ultrasound System recalled | Philips Ultrasound | Labeling Errors | Nationwide |
| Device | CLASS II | GmbH Spectralis with Flex Module recalled by Heidelberg Engineering | Heidelberg Engineering | Potency & Assay | Nationwide |
| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |