O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients
Summary
The FDA issued a Class II for O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D by Medtronic Navigation, Inc.-Littleton. Reason: Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, a.
Details
Source
Device Recall
External ID
Z-2026-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Lot/Code Info: GTIN: 00643169639683 00763000616441 00763000616465 00763000616526 00763000616533 00763000616564 00763000616571 Serial Numbers: C3578 C3421 C3606 C3645 C3641 C3589 C3604 C3537 C3551 C1595 C1437 C3469 C3635 C3626 C3389 C3647 C3407 C3713 C3607 C1629
Quantity Affected: 20 units
Reason for Recall
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-26
Company
Littleton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Navigation, Inc.-Littleton has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.-Littleton) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc.-Littleton have FDA actions?
Medtronic Navigation, Inc.-Littleton has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2026-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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