FDA recall Z-2734-2017

Product

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

Reason for recall

Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

Distribution

AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom

Key facts

Status

Terminated

Initiation date

2017-06-06

Report date

2017-07-26

Termination date

2018-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2017