Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sony Inc.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Sony Inc. see related information
Date Initiated by Firm January 13, 2015
Date Posted September 16, 2015
Recall Status1 Terminated 3 on April 26, 2017
Recall Number Z-2771-2015
Recall Event ID 71657
Product Classification Camera, television, surgical, without audio - Product Code FWB
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.
Code Information Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145   Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157
Recalling Firm/
Manufacturer		 Sony Medical Systems
1 Sony Dr
Park Ridge NJ 07656-8002
For Additional Information Contact Ms. Theresa M. Alesso
866-789-7669
Manufacturer Reason
for Recall		 Tthe medical monitor has either not turned on or has lost image during clinical use.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-