Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2771-2015Class II

Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display...

Sony Medical Systems / initiated 2015-01-13 / Terminated / root cause: design

Sony Medical Systems began a recall of Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode... on . FDA classified it as Class II and gives the reason as "Tthe medical monitor has either not turned on or has lost image during clinical use". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2771-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sony Medical Systems
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.
Product code
FWB Camera, Television, Surgical, Without Audio
Reason for recall
Tthe medical monitor has either not turned on or has lost image during clinical use.
Root cause tag
design
FDA root cause
Device Design
Action
Sony Corporation sent an URGENT: MEDICAL DEVICE FIELD ACTION field letter dated January 13, 2015. Customers are asked to affix the warning sticker to the rear of the monitor and place the adhesive seal over the AC inlet. If the firm does not possess an AC adaptor (AC-110MD) for each of the affected monitors, stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit the appropriate failure mode. Questions can be directed to 866-789-SONY (7669) between 8:00 am and 8:00 pm Monday through Friday.
Quantity in commerce
4952 units (1016 US; 3936 OUS)
Distribution
Worldwide Distribution - US Distribution to the states of : AZ, CA, NC, PA, IA, OH and FL., and to the countries of : China, Japan, Taiwan, South Korea and Indonesia.
Product codes and lots
Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145   Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2771-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2771-2015Class IITerminatedVoluntary: Firm initiated