The Recall Desk
Agency classClass IIOur severity:HighFDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
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:

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