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PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

FDA Device Recall #Z-1238-2022 — Class II — April 21, 2022

Recall Summary

Recall Number Z-1238-2022
Classification Class II — Moderate risk
Date Initiated April 21, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Oakworks Inc
Location New Freedom, PA
Product Type Devices
Quantity 130

Product Description

PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

Reason for Recall

Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

Distribution Pattern

US Nationwide distribution in the states of MA, NJ, and PA.

Lot / Code Information

UDI-DI: 00817463026399 Serial Numbers: PXR769629 PXR769630 PXR769631 PXR769632 PXR769633 PXR769634 PXR769635 PXR769636 PXR769637 PXR769638 PXR769639 PXR769640 PXR769641 PXR769642 PXR769643 PXR769644 PXR769645 PXR769646 PXR769647 PXR769648 PXR769649 PXR769650 PXR769651 PXR769652 PXR769653 PXR769654 PXR769655 PXR769656 PXR769657 PXR769658 PXR769730 PXR769731 PXR769732 PXR769733 PXR769734 PXR769735 PXR769736 PXR769737 PXR769738 PXR769739 PXR769740 PXR769741 PXR769742 PXR769743 PXR769744 PXR769745 PXR769746 PXR769747 PXR769748 PXR769749 PXR769750 PXR769751 PXR769752 PXR769753 PXR769754 PXR769755 PXR769756 PXR769757 PXR769758 PXR769759 PXR769760 PXR769761 PXR769762 PXR769763 PXR769764 PXR769765 PXR769766 PXR769767 PXR769768 PXR769769 PXR769770 PXR769771 PXR769772 PXR769773 PXR769774 PXR769775 PXR769776 PXR769777 PXR769778 PXR769779 PXR769780 PXR769781 PXR769782 PXR769783 PXR769784 PXR769785 PXR769786 PXR769787 PXR769788 PXR769789 PXR769790 PXR769791 PXR769792 PXR769793 PXR769794 PXR769795 PXR769796 PXR769797 PXR769798 PXR769799 PXR769800 PXR769801 PXR769802 PXR769803 PXR769804 PXR769805 PXR769806 PXR769807 PXR769808 PXR769809 PXR769810 PXR769811 PXR769812 PXR769813 PXR769814 PXR769815 PXR769816 PXR769817 PXR769818 PXR769819 PXR769820 PXR769821 PXR769822 PXR769823 PXR769824 PXR769825 PXR769826 PXR769827 PXR769828 PXR769829

Other Recalls from Oakworks Inc

Recall # Classification Product Date
Z-0729-2024 Class II Ultrasound EA (Ergonomic Advantage) table versi... Dec 5, 2023
Z-0728-2024 Class II Ultrasound EA (Ergonomic Advantage) table versi... Dec 5, 2023
Z-0730-2024 Class II Ultrasound EA (Ergonomic Advantage) table versi... Dec 5, 2023
Z-0727-2024 Class II Ultrasound EA (Ergonomic Advantage) table versi... Dec 5, 2023
Z-1239-2022 Class II Oakworks Bed (Emergency Field Bed); Model No. O... Apr 21, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.

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