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ZOLL Code Writer

Zoll Medical Corporation · Model 9211-0072 · UDI-DI 00847946021887

NSX DXJ

510(k) clearances

168

Adverse events (5 deaths)

Recalls

Facilities

Description

Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems.

Recalls

Date	Firm	Reason
2022-07-13	bioMerieux, Inc.	There are 7 reported software anomalies that may affect use of the device.
2017-05-31	Soft Computer Consultants, Inc.	Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR
2017-01-23	Merge Healthcare, Inc.	A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
2016-10-06	Soft Computer Consultants, Inc.	Software error. Potential for incorrect results
2016-10-06	Soft Computer Consultants, Inc.	Software error. Potential for incorrect results
2015-07-29	BD LIFE SCIENCES	The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP)
2013-06-21	Picis Inc.	Notes associated with prescription are not printed to the prescription or to the patient chart.
2013-05-10	Siemens Healthcare Diagnostics, Inc.	Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review du
2012-07-23	Cisco Systems Inc	Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlac
2012-07-16	Roche Molecular Systems, Inc.	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.