FDA recall Z-2656-2023

Product

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

Reason for recall

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-09-08

Report date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wuxi, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2656-2023