Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect
Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing defect affecting the operation of a medical device used for patient monitoring, which poses a risk of harm if the device fails, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 40 lithium-ion rechargeable batteries (REF: 989803176201, Lot 2018-28) intended for use with the Philips MX40 Wearable Monitor. The recall is due to a manufacturing defect that may affect the operation of the monitor. The MX40 is indicated for use by health care professionals to monitor and record physiological parameters of patients in hospital environments and during transport.
The affected batteries were distributed nationwide in the states of AK, CA, CO, IN, MI, NC, ND, NM, OR, TN, TX, and UT. The source text does not specify specific dates of distribution or the exact number of units affected beyond the quantity of 40 batteries listed in the structured data.
Health care professionals should stop using the affected batteries and contact Philips North America for further instructions. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, a
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 40
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 (1)
- Lot 2018-28
Distribution
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