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DataLITE CA2 Battery Charger

BIOMETRICS LIMITED · Model CA2 · UDI-DI 05060481690614

510(k) clearances

Adverse events

Recalls

Facilities

Description

Mains powered battery charging unit for up to 8 wireless DataLITE sensors (LE230, W series Goniometers, Z series Torsiometers, AD2, ACL500). Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Recalls

Date	Firm	Reason
2023-05-31	Trexo Robotics Holdings Inc.	Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
2020-06-08	Hocoma AG	The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05	Interactive Motion Technologies, Inc.	Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.