FDA recall Z-0433-2024

Stryker Medical Division of Stryker Corporation · Class II · device

Product

ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.

Reason for recall

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Distribution

Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Key facts

Status
Ongoing
Initiation date
2023-08-30
Report date
2023-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0433-2024