The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1514-2015·Announced 2015-04-29

Sony Medical Monitor LMD-1951MD Recalled for Power and Image Failures

Sony Latin America is recalling 4,764 LMD-1951MD medical monitors because they may fail to turn on or lose image during clinical use.

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 is classified as FDA Class II, and the hazard involves a medical device failing during clinical use, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Sony Latin America is recalling 4,764 units of the Sony Medical Monitor LMD-1951MD 19 inch. The recall was initiated because the monitors have either not turned on or have lost image during clinical use.

The affected units were distributed worldwide, including in the United States (Florida and North Carolina) and in Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, the Dominican Republic, and South Korea. The specific serial number ranges for the recalled units are 3000038-3004884, 3100035-3100058, and 3100065-3100145.

Healthcare facilities and users should check their inventory for these serial numbers and contact Sony Latin America for instructions on how to proceed with the recall.

The recalled product

Product
Sony Medical Monitor LMD-1951MD 19 inch
Manufacturer
Sony Latin America
Affected units
4,764

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 (3)

  • Serial number range: 3000038-3004884
  • 3100035-3100058
  • 3100065-3100145.

Distribution

Distributed in 2 states:

Similar recalls