FDAJanuary 30, 2025device

Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye

What to do

FDA enforcement status: Ongoing

Brands named

telcare

UPCs

00859519002407

Recall history

No related federal recalls on record for this brand yet.

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Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; — Recall Details · AllClear