FDA recall Z-0919-2022

Product

MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

Reason for recall

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

Distribution

US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey

Key facts

Status

Terminated

Initiation date

2022-03-16

Report date

2022-04-20

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2022