FDA Medical Device Recalls (openFDA)
Sony Latin America: Sony Medical Monitor LMD-1951MD 19 inch
- Recall number
- Z-1514-2015
- Recalling firm
- Sony Latin America
- Product
- Sony Medical Monitor LMD-1951MD 19 inch
- Status
- Terminated
- Initiated
- 2015-03-05
- Posted
- 2015-04-23
- Terminated
- 2016-12-14
- Reason
- Monitor has either not turned on or has lost image during clinical use.
- 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
- 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.
- Lot, serial or model codes
- Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQM
- Firm FEI
- 3010052497
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28