Sphygmomanometer

Recall Summary Welch Allyn Inc is recalling sphygmomanometers (blood pressure measurement devices) distributed to hospitals, pharmacies, and laboratories in New Zealand due to a software issue that requires an upgrade. The recall is classified as Class I, indicating a serious potential health risk. The software upgrade is necessary to address the identified problem with the device.

Recalling firm

Universal Specialities Ltd trading as USL Medical

Product

Sphygmomanometer. [Device]. Model: Connex Spot Monitor (CSM) devices using the Welch Allyn Service Tool

Reason

The manufacturer has identified that Connex Spot Monitor devices may show false leak-test failures during blood pressure calibration when using Welch Allyn Service Tool software version 1.11 or earlier. This occurs during the leak-test step of the calibration process and can cause the overall calibration to fail. The manufacturer has released Welch Allyn Service Tool version 1.11.2 to fix this issue, and customers are advised to download and install the updated software.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-04-24

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/ba426c50-3d91-4159-8e78-679d4947d778