Z-0433-2024 Class II Ongoing
FDA device recall Z-0433-2024 was initiated by Stryker Medical Division of Stryker Corporation on August 30, 2023 and is designated Class II. Reason for recall: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- August 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 Pattern
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Code Information
UDI-DI (GTIN): 07613327541311. Serial numbers: 2201000173, 2110001895, 2203001506, 2110000413, 2110000411, 2208002037, 2208002030, 2208002019& 2212000691