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U.S. Department of Health and Human Services

Class 2 Device Recall Sony Medical Monitor LMD1951MD 19 inch

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  Class 2 Device Recall Sony Medical Monitor LMD1951MD 19 inch see related information
Date Initiated by Firm March 05, 2015
Date Posted April 23, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1514-2015
Recall Event ID 70702
Product Classification Camera, surgical and accessories - Product Code KQM
Product Sony Medical Monitor LMD-1951MD 19 inch
Code Information Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.
Recalling Firm/
Manufacturer		 Sony Latin America
5201 Blue Lagoon Dr
Miami FL 33126-2064
For Additional Information Contact Luis Claro
305-260-4091
Manufacturer Reason
for Recall		 Monitor has either not turned on or has lost image during clinical use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action SOLA sent an URGENT MEDICAL DEVICE FIELD ACTION dated March 2, 2015, to all affected customers. Within that notification SOLA requests that you send the customer letter included in Attachment 1 of this notification to all customers who have purchased the affected monitors from you. The letter instructs customers who already possess an AC adapter for each of their affected monitors to only use the AC adaptor when the monitors are in use. If you have units in inventory that can be provided with an AC adapter, we will provide under separate cover kits that contain: 1) a sticker warning and 2) an adhesive seal to go over the AC outlet and 3) correction instructions document. If you have units in inventory that cannot be accompanied by an AC adapter, for each of these affected monitors, do not ship the unit until the permanent corrective action described below has been applied. Please complete the MEDICAL DEVICE RECALL RETURN RESPONSE included in Attachment 2 to the contact person identified on the form. Please contact me below if you have any questions. 305-260-4000 Hours of operation: 8am to 8pm (Monday through Friday, excluding holidays).
Quantity in Commerce 4,764 units
Distribution Worldwide Distribution - US Distribution to the states of : FL and NC., and to the countries of : Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, Dominican Republic, and South Korea.
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.
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