Sony Medical Monitors Recalled for Failure to Power On or Display Image
Sony Medical Systems is recalling 4,952 medical monitors that 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 to display images during clinical use, which poses a risk of harm where injury has not yet been reported.
Plain-English summary
Sony Medical Systems is recalling 4,952 units of 19-inch medical grade liquid crystal display (LCD) monitors. The affected models are the Sony LMD-1951MD, Sony LMD1951MD/BS, and Sony LMD-1951MC (Foreign). These devices utilize light-emitting diode (LED) backlight technology.
The recall was initiated because the medical monitors have either not turned on or have lost image during clinical use. The affected units were distributed worldwide, including in the United States (Arizona, California, North Carolina, Pennsylvania, Iowa, Ohio, and Florida) and in China, Japan, Taiwan, South Korea, and Indonesia.
Healthcare facilities should contact Sony Medical Systems for instructions on how to return the affected devices. Specific serial number ranges for the LMD-1951MD are 3000038-3004884, 3100035-3100058, and 3100065-3100145. For the LMD-1951MC (Foreign), the serial number ranges are 5000001-5001925 and 5100001-5100157.
The recalled product
- Product
- Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
- Manufacturer
- Sony Medical Systems
- Category
- Medical Device — Medical Monitor
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)
- Sony LMD-1951MD 3000038-3004884
- 3100035-3100058
- 3100065-3100145 Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157
Distribution
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