FDA recall Z-1950-2024

Product

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

Reason for recall

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2024-05-03

Report date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2024