Z-0857-2016Class II

Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or...

Name: Z-0857-2016 Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or...
Creator: Philips Electronics North America Corporation
Published: 2015-11-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-11-25 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) on 2015-11-25. FDA classified it as Class II and gives the reason as "Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0857-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-02-23
Terminated: 2017-09-06
Recalling firm: Philips North America LLC
Product: Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Root cause tag: software
FDA root cause: Software Design Change
Action: Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
Quantity in commerce: 5569 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
Product codes and lots: Software B.O

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0857-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0856-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23
Z-0857-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23
Z-0858-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

Product code MHX

K102495Class IIM3290b Intellivue Information Center Software, Release A.0Philips Medical Systems / cleared 2010-09-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)