FDA Medical Device Recalls (openFDA)
SonarMed Inc: SonarMed AirWave Monitor, Model Number M0001
- Recall number
- Z-2450-2019
- Recalling firm
- SonarMed Inc
- Product
- SonarMed AirWave Monitor, Model Number M0001
- Status
- Terminated
- Initiated
- 2017-04-17
- Posted
- not on file
- Terminated
- 2020-07-16
- Reason
- Potential for the presence of two error codes which would make the monitor inoperable.
- Root cause
- Software design
- Action
- April 2017, firm notifications were made in person at the time of the visit to upgrade the firmware. All monitors that had not been distributed were upgraded to the new firmware. All subsequent shipments will have the updated firmware.
- Quantity
- 16 units
- Distribution
- CA & TX
- Lot, serial or model codes
- UDI Numbers: (01)00851334007001(11)130426(21)339 (01)00851334007001(11)130502(21)342 (01)00851334007001(11)131105(21)365 (01)00851334007001(11)140522(21)369 (01)00851334007001(11)140522(21)373 (01)00851334007001(11)150609(21)379 (01)00851334007001(11)150609(21)381 (01)00851334007001(11)150609(21)382 (01)00851334007001(11)150630(21)383 (01)00851334007001(11)150630(21)385 (01)00851334007001(11)150630(21)386 (01)00851334007001(11)150630(21)388 (01)00851334007001(11)150630(21)389 (01)00851334007001(11)150630(21)390 (01)00851334007001(11)150701(21)391 (01)00851334007001(11)150701(21)393
- 510(k) numbers
- K143042
- PMA numbers
- not on file
- Product code
- OQU
- Firm FEI
- 3009923584
- Firm city
- Carmel
- Firm state
- IN
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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