Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
FDA Recall Z-0160-2011 · Posted 2010-10-28
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Recalling FirmEdwards Lifesciences, Llc
Recall StatusTerminated
Product CodeDXG
Date Initiated2010-06-25
Date Terminated2011-05-24
Product Quantity20 units
Reason for Recall
The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
Firm Action
Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number.
Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned.
For any questions regarding this recall call (949) 250-2007.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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