CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

The product is Pathfinder SL recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling The product is Pathfinder SL, distributed nationwide in the US. The recall was initiated on 11 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 1.6.0.

Quantity recalled114

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1831-2012
FDA event ID: 61913
Recalling firm: Spacelabs Healthcare, Issaquah, WA
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2012
FDA classified: 20 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

11 May 2012	Recall initiated by company
20 Jun 2012	Classified by FDA	+40 days
27 Jun 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.

Where it was distributed

Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.

Nationwide Nevada Vermont

Questions about this recall

Why was it recalled?

Which lots are affected?

Version 1.6.0.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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