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URGENT: MEDICAL DEVICE FIELD ACTION
MODELS LMD-1951MD, LMD-1951MD/BS, LMD-1951MD/HD and LMD-1951MD.B
Serial number: 3000038-3004884, 3100035-3100058, 3100065-3100145
In January 2015, Sony Electronics Inc. ("SEL") initiated a voluntary field action of its LMD-1951MD 19 inch medical grade liquid crystal display (LCD) monitors with light-emitting diode (LED) backlight technology. On July 27, 2015, SEL added model number LMD-1951MD/BS to this field action, on October 28, 2015 SEL added model number LMD-1951MD/HD to this field action and on December 4, 2015, SEL added model LMD-1951MD.B to this field action . As a customer, you should have already received the information provided below. If you have not received this information or responded to the letter from your supplier, please be sure to follow the "Immediate Action" instructions below and complete and submit the Acknowledgment and Receipt Form. It is very important for you to complete and submit the Acknowledgment and Receipt Form (if you have not already contacted your distributor or SEL) so that SEL can work with you to replace affected boards. In the meantime, continue to follow the instructions in the customer letter.
Description of Issue
In some situations, a LMD-1951MD, LMD-1951MD/BS, LMD-1951MD/HD or LMD-1951MD.B medical monitor or similar model not distributed by SEL in the United States has either not turned on or has lost image during clinical use (hereinafter "the failure mode"). Sony Corporation’s investigation indicates that the issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. The failure mode does not occur when an AC adapter (AC-110MD) is used with the monitor.
If you possess an AC adapter (AC-110MD) for each of your affected monitors, only use the AC adaptor when the monitors are in use.
For each of the affected monitors for which you have an AC adapter (AC-110MD) follow the Instructions Document (AC Adaptor Setting Procedure and Completion Report Doc No. 0-422-947-01 ver.1.3) to (1) affix the warning sticker (warning that the AC inlet should not be used) to the rear of the monitor; and (2) place the adhesive seal over the AC inlet.
If you do not possess an AC adapter (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.
To date, Sony Corporation and SEL have not received any reports of adverse events due to this failure mode and all but one of the reports from the field regarding this failure mode have been from outside of the United States. Based on SEL's investigation, SEL believes that this failure mode is not likely to result in adverse health consequences because: (1) the device IFU includes a precautionary warning which recommends the end user to use more than one device or to prepare a spare device to help prevent against loss of visualization; (2) it is believed that most facilities in the U.S. that use the device (e.g., hospitals and major surgery centers) have guidelines that prescribe having backup systems in place to enable continuation of the operation in the event that loss of visualization occurs during a non-critical juncture of the surgery (e.g., a non-hemorrhagic event); (3) for systems that have an eyecup that allows for direct visualization of the operating field, the surgeon can revert to using the eyecup of the scope in cases where the surgery is not at a critical juncture to pause, end, or, in some cases (e.g., some gastrointestinal procedures), complete the procedure; and (4) even during a critical juncture, in most cases, the surgeon will have time to intervene (e.g., conversion to open surgery) to prevent impairment of a body function or permanent damage to a body structure. If the failure mode occurs during the pre-operative period, the procedure may need to be postponed causing patient and user inconvenience. In this scenario, the patient has not yet been anesthetized.
If the failure mode occurs during the perioperative period,
It would be reasonably expected that the patient would experience no injury or limited injury (transient, minor impairment) because the patient would be, at most, subjected to a prolonged procedure (and potentially exposed to additional anesthesia) while a backup system or alternative technique is being used to complete the operation.
In order for the reasonable worst-case injury (i.e. tearing or laceration of a structure, loss of hemostasis causing a hemorrhagic complication) to occur, all of the following events would need to be present: (1) prolonged loss of visualization due to alternative visualization not becoming available in a reasonable time frame; (2) loss of visualization at the precise moment of a critical juncture of the procedure which could not be interrupted (these moments are of very limited duration compared to the overall duration of the procedure); and (3) the surgeon is unable to temporarily hold the structure in place until visualization is restored. The likelihood of these events all happening at the exact moment of loss of visualization is improbable. There could be certain complications if a patient needs to be converted to open surgery.
Sony Corporation is taking this action to reduce the risk of this failure mode from occurring.
As a permanent corrective action, SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit this failure mode. You will be contacted after completion and return of the Acknowledgment and Receipt Form with respect to the replacement of the power board. Until the unit(s)' power board has been replaced, continue to follow the Immediate Customer Action above.
How to Identify Affected Units
SONY LMD-1951MD, LMD-1951MD/BS, LMD-1951MD/HD and LMD-1951MD.B monitors with the following serial numbers are affected by this field action: 3000038-3004884, 3100035-3100058, 3100065-3100145. Affected units can be identified by:
Confirming the serial number (7 digits) printed in the warranty certificate; or
Confirming the serial number on the product label affixed at the rear of the product:
Thank you very much for your continued loyalty to SEL products. The quality of our product is our primary concern. Quality is important to SEL. It is the foundation of our trust with you. We apologize for any inconvenience this issue may cause and appreciate your continued support of SEL.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Please contact Sony via telephone or email as per below if you have any questions:
Telephone*: 866-789-SONY (7669)
* Hours of operation: 8:00AM to 8:00PM EST (Monday through Friday, excluding holidays)
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