Z-1714-2008

Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by...

Name: Z-1714-2008 Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by...
Creator: Cardiac Science Corporation
Published: 2008-01-23
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2008-01-23 / Terminated / root cause: labeling and UDI

FDA source

Cardiac Science Corporation began a recall of Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated... on 2008-01-23. The reason FDA records is "Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1714-2008
Status: Terminated
Initiated: 2008-01-23
Posted: 2008-09-17
Terminated: 2011-12-08
Recalling firm: ZOLL Medical Corporation
Product: Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 1/23/08 the firm issued a letter titled "9055 Electrode Adaptor IFU Update" to consignees sent via certified return receipt requested. Enclosed with the letter is an updated Instructions For Use, part number 70-00180-01, revision C. Consignees were advised to discard their old Instructions For Use. For assistance, contact Cardiac Science at 1-888-466-8686.
Quantity in commerce: 63
Distribution: Distributed Nationwide US and Canada and Internationally to: Norway and Guam
Product codes and lots: Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, and 6838

Product code MKJ

K010214Class IIIFirstsave Biphasic Model #9200 and 9210Survivalink Corp. / cleared 2001-02-22

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)