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Terminated

Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810

FDA Recall Z-0124-2008 · Posted 2008-01-30

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeDPS
Date Initiated2007-09-12
Date Terminated2016-08-16
Product Quantity266 units

Reason for Recall

Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

Firm Action

Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.

Root Cause

Software change control

Distribution Pattern

Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020708PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIESPhilips Medical Systems, Inc. · 2002-04-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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