The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2717-2016·Announced 2016-09-14

Aribex Recalls NOMAD Pro2 X-Ray Systems Due to Battery Fire Risk

Aribex Inc is recalling 16,871 NOMAD Pro2 X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, smoke, 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 fire hazard (ignition) and significant injury risk (burns) from a structural defect in the battery pack, which aligns with the rubric criteria for 'Severe' (significant injury reports or structural defect).

Plain-English summary

Aribex Inc is recalling 16,871 units of the NOMAD Pro2 Packaged X-Ray System, including various part numbers and configurations such as the Vet and Black models. The recall covers units distributed across all 50 U.S. states, Puerto Rico, and numerous international locations.

The recall was initiated after the firm received customer complaints that the handsets appeared to overheat, melt, smoke, and/or ignite. An investigation determined that the internal lithium-ion batteries entered a thermal runaway condition due to a short circuit on the battery pack PCB.

Consumers should stop using the affected devices immediately and contact Aribex Inc for instructions on how to proceed with the recall.

The recalled product

Product
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System…
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 (17)

  • Part Number 08500021 - Serial Number Range XD-100921-05 - XD-150109-11
  • 10000 - 20811
  • XD-140929-39 - XD-150123-20
  • Part Number 08500022 - Serial Number Range XE-130528-03 - XE-150123-38
  • 10000 - 20541
  • XE-140908-32 - XE-150123-40
  • Part Number 08500023 - Serial Number Range XF-121008-05 - XF-150205-03
  • 10003 - 20032
  • XE-150205-01
  • Part Number 08500024 - Serial Number Range XG-130520-01 - XG-141210-05
  • 1000 - 20019
  • Part Number 08500025 - Serial Number Range XI-140303-02 - XI-150210-9
  • XI-150202-04 - XI-150210-19
  • Part Number 08500026 - Serial Number Range 10039 - 20041
  • Part Number 08500027 - Serial Number Range 1000 - 20006
  • Part Number 08500028 - Serial Number Range 10000 - 20030
  • Part Number 08500029 - Serial Number Range 10000.

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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