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U.S. Department of Health and Human Services

Class 2 Device Recall General Purpose Temperature Probe

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 Class 2 Recall
General Purpose Temperature Probe
see related information
Date Posted August 13, 2013
Recall Status1 Terminated on January 02, 2014
Recall Number Z-1959-2013
Recall Event ID 65857
Premarket Notification
510(K) Number
K051873 
Product Classification Thermometer, Electronic, Clinical - Product Code FLL
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.
Code Information GE product number M1024229
Recalling Firm/
Manufacturer
Vital Signs Devices, a GE Healthcare Company
20 Campus Rd
Totowa, New Jersey 07512-1210
Manufacturer 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 Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FLL and Original Applicant = GE HEALTHCARE
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