Z-1959-2013Class II

Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a...

Name: Z-1959-2013 Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a...
Creator: Vital Signs Devices, a GE Healthcare Company
Published: 2013-07-18
License: https://open.fda.gov/license/

Vital Signs, Inc. / initiated 2013-07-18 / Terminated

FDA source

Vital Signs Devices, a GE Healthcare Company began a recall of 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... on 2013-07-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1959-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-18
Posted: 2013-08-13
Terminated: 2014-01-02
Recalling firm: Vital Signs, Inc.
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.
Product code: FLL Continuous Measurement Thermometer
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
FDA root cause: Use error
Action: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 23, 2013 via Fed Ex beginning on July 29, 2013 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE will update the Instructions for Use (IFU) and pouch label with new content related to insertion locations. GE has will also place the probe (M1024229) on quality hold until the new labeling changes are implemented. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at 1-800-588-7044 (Domestic) or Vital Signs Customer Service at 1-800-932-0760 (international). Hours of operation: 8:00 am EST to 6:00 pm EST.
Quantity in commerce: 12,239 units (5,002 units US, 7,237 units OUS).
Distribution: 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.
Product codes and lots: GE product number M1024229

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1959-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code FLL

K051873Class IIDisposable Temperature, Skin and Esophageal ProbesGE Healthcare / cleared 2005-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)