The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2716-2016·Announced 2016-09-14

Aribex Recalls NOMAD Pro X-Ray Systems Due to Battery Fire Risk

Aribex Inc is recalling NOMAD Pro X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, melting, smoking, or ignition.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and ignition due to battery thermal runaway, which constitutes a significant injury hazard. This aligns with the rubric for Severe (4) recalls involving significant injury reports or high-risk defects.

Plain-English summary

Aribex Inc is recalling specific models of the NOMAD Pro Packaged X-Ray System, including the Vet, Europe, Remote Config., and JP versions. The recall involves 16,871 units distributed across the United States, Puerto Rico, and numerous international locations. Affected part numbers include 08500009, 08500011, 08500013, 08500017, and 08500019, with specific serial number ranges detailed in the agency's structured data.

The recall was initiated after the firm received customer complaints indicating that the handsets had overheated, melted, smoked, or ignited. An investigation determined that the internal lithium-ion batteries entered a thermal runaway condition due to a short circuit on the battery pack PCB. This defect poses a risk of fire and potential injury to users.

Users of these devices should stop using the affected handsets immediately. Aribex Inc is the recalling firm and is responsible for managing the recall process. Consumers and healthcare providers should contact the manufacturer for instructions on how to proceed with the recall.

The recalled product

Product
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP…
Manufacturer
Aribex Inc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
16,871

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Part Number 08500009 - Serial Number Range BX-011008-01 - XB-141219049
  • Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02
  • Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13
  • Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50
  • Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 2 recalled by Aribex Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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