ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.

FDA Device Recall #Z-0434-2024 — Class II — August 30, 2023

Recall Summary

Recall Number Z-0434-2024
Classification Class II — Moderate risk
Date Initiated August 30, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Medical Division of Stryker Corporation
Location Portage, MI
Product Type Devices

Product Description

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.

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.

Lot / Code Information

UDI-DI (GTIN): 07613327541304 . Serial number: 2212000205

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Z-0429-2024 Class II ProCuity bed series, model number 3009, item nu... Aug 30, 2023
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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.