Z-2314-2008

Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an...

Name: Z-2314-2008 Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an...
Creator: Spacelabs Healthcare, Incorporated
Published: 2008-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-07-02 / Terminated / root cause: manufacturing process

FDA source

Spacelabs Healthcare, Incorporated began a recall of Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink... on 2008-07-02. The reason FDA records is "Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2314-2008
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-09-20
Terminated: 2011-06-07
Recalling firm: GE Healthcare
Product: Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00 Spacelabs Medical Issaquah, WA USA"
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Starting July 3, 2008 the firm issued a "MEDICAL DEVICE CORRECTION" letter notifying their customers of the potential hazards with the use of probe adapter, PN 700-031-00. All letters have a return receipt to verify each customer received the medical device correction letter. The firm will replace all PN 700-0031-00 adaptors with a replacement adaptor from their initial distributor. The firm initiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction letter to the firm's customers. The firm has requested their customers to throw away any adapter that is being recalled. Technical Support will be available for customer questions and technical questions and to ensure each unit is upgraded. Contact Spacelabs Healthcare at 425-657-7200 ext 5970 if you have questions.
Quantity in commerce: 3,733
Distribution: Nationwide and Worldwide to medical facilities.
Product codes and lots: Lot numbers: OSC 01/07, OSC 02/07, OSC 03/07, OSC 04/07 and OSC 07/07.

Product code DSI

K972502Class IISpacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. / cleared 1998-05-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)