High FDA (Devices)·Z-1349-2019·Announced 2019-05-22

Stanley Security M200 Fall Monitoring System Recalled for Damaged Capacitor

Stanley Security Solutions is recalling 1,101 M200 Fall Monitoring Systems due to a damaged capacitor on the printed circuit board.

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 involves a medical device with a component defect that poses a risk of harm, but no injuries or illnesses have been reported, fitting the criteria for a High severity score.

Plain-English summary

Stanley Security Solutions Inc is recalling 1,101 units of the M200 Fall Monitoring System. The recall is due to a damaged capacitor on the printed circuit board.

The affected units were distributed in Connecticut, Florida, Ohio, Oklahoma, Texas, Washington, West Virginia, and Canada. The recall covers specific serial numbers listed in the official FDA record.

Consumers should stop using the affected devices and contact Stanley Security Solutions for further instructions.

The recalled product

Product: M200 Fall Monitoring System
Manufacturer: Stanley Security Solutions Inc
Category: Medical Device — Fall Monitoring System
Hazard: electrical-defect
Affected units: 1,101

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 (20)

Serial Numbers: 68015
68016
68017
68018
68019
68020
68021
68022
68023
68024
68025
68026
68027
68028
68029
68030
68031
68032
68033
68034

Distribution

Distributed in 7 states:

Same manufacturer · Stanley Security Solutions Inc

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Same hazard · electrical defect