Events

Recall of Device Recall Sony Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sony Medical Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71657
  • Event Risk Class
    Class 2
  • Event Number
    Z-2771-2015
  • Event Initiated Date
    2015-01-13
  • Event Date Posted
    2015-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138605
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, television, surgical, without audio - Product Code FWB
  • Reason
    Tthe medical monitor has either not turned on or has lost image during clinical use.
  • 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.

Device

Device Recall Sony Inc.
  • Model / Serial
    Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145   Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    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

Manufacturer

Sony Medical Systems
  • Manufacturer Address
    Sony Medical Systems, 1 Sony Dr, Park Ridge NJ 07656-8002
  • Source
    USFDA