Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 16, 2015
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended u
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems, Inc. recalled Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by t… - a moderate-severity action.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by t… was recalled by Philips Medical Systems, Inc. in December 16, 2015. Reason: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification. Check the official notice for the remedy. Verify recall #Z-0374-2016 with the FDA Devices before acting.
The recall
Philips Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification.
- Moderate
- severity level
- 10K units
- affected scope
- Class II
- classification
- December 16, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0374-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0374-2016) was formally reported on December 16, 2015, with the manufacturer initiating the action on December 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 10,013 units.
The documented reason for this recall is: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,013 units
Related Recalls
6
3 from same agency
Product description
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Reason for recall
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0374-2016 |
| Date reported | December 16, 2015 |
| Date initiated | December 19, 2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 10,013 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLAND… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0374-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.. Recalled by Philips Medical Systems, Inc.. Units affected: 10,013 units.
Why was this product recalled? ▼
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0374-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0374-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 16, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.