Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital S...
FDA Device Recall #Z-1959-2013 — Class II — July 18, 2013
Recall Summary
| Recall Number | Z-1959-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vital Signs Devices, a GE Healthcare Company |
| Location | Totowa, NJ |
| Product Type | Devices |
| Quantity | 12,239 units (5,002 units US, 7,237 units OUS). |
Product Description
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
Reason for Recall
GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.
Lot / Code Information
GE product number M1024229
Other Recalls from Vital Signs Devices, a GE Healthcare ...
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| Z-0330-2013 | Class II | Corometrics Qwik Connect Plus Spiral Electrode-... | Oct 16, 2012 |
| Z-1972-2012 | Class II | enFlow IV Fluid Warmer (510k name: EFLOW IV FLU... | Feb 20, 2012 |
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.