Recall Z-2717-2016— Aribex Inc

Name: FDA recall Z-2717-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-18

Class II · Terminated

Class II FDA medical device recall by Aribex Inc, initiated 2016-07-18, terminated 2017-07-26. It names one FDA 510(k) clearance: K081664. 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, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029. Reason: Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB..

Recalling firm: Aribex Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Terminated: 2017-07-26
Firm location: Charlotte, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K081664 — NOMAD PRO X-RAY SYSTEMAribex, Inc.·cleared 2008-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029

Reason for recall

Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.

Data sourced from openFDA. This site is unofficial and independent of the FDA.