Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 19, 2016
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls ve…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Oec Medical Systems, Inc recalled OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: Th… - a moderate-severity action.
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: Th… was recalled by Ge Oec Medical Systems, Inc in October 19, 2016. Reason: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential…. Check the official notice for the remedy. Verify recall #Z-0071-2017 with the FDA Devices before acting.
The recall
Ge Oec Medical Systems, Inc issued this moderate-severity FDA Devices recall-GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential….
- Moderate
- severity level
- Class II
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0071-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0071-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on September 23, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Oec Medical Systems, Inc is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 148 total.
The documented reason for this recall is: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, res… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
148 total
Related Recalls
6
3 from same agency
Product description
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.
Reason for recall
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0071-2017 |
| Date reported | October 19, 2016 |
| Date initiated | September 23, 2016 |
| Recalling firm | Ge Oec Medical Systems, Inc |
| Firm location | Salt Lake City, UT |
| Affected scope | 148 total |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0071-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.. Recalled by Ge Oec Medical Systems, Inc. Units affected: 148 total.
Why was this product recalled? ▼
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0071-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0071-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 19, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.