Recall Z-1959-2013— Vital Signs Devices, a GE Healthcare Company

Name: FDA recall Z-1959-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-18

Class II · Terminated

Class II FDA medical device recall by Vital Signs Devices, a GE Healthcare Company, initiated 2013-07-18, terminated 2014-01-02. It names one FDA 510(k) clearance: K051873. Product: 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: 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.

Recalling firm: Vital Signs Devices, a GE Healthcare Company
Classification: Class II
Status: Terminated
Initiated: 2013-07-18
Terminated: 2014-01-02
Firm location: Totowa, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K051873 — DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBESGE Healthcare·cleared 2005-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.