Z-1514-2015Class II

Sony Medical Monitor LMD-1951MD 19 inch

Name: Z-1514-2015 Sony Medical Monitor LMD-1951MD 19 inch
Creator: Sony Latin America
Published: 2015-03-05
License: https://open.fda.gov/license/

Sony Latin America Inc / initiated 2015-03-05 / Terminated / root cause: manufacturing process

FDA source

Sony Latin America began a recall of Sony Medical Monitor LMD-1951MD 19 inch on 2015-03-05. FDA classified it as Class II and gives the reason as "Monitor has either not turned on or has lost image during clinical use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1514-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2015-04-23
Terminated: 2016-12-14
Recalling firm: Sony Latin America Inc
Product: Sony Medical Monitor LMD-1951MD 19 inch
Product code: KQM Camera, Surgical And Accessories
Reason for recall: Monitor has either not turned on or has lost image during clinical use.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1514-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1514-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23

Product code KQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)