Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 12, 2017
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospita
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsucces…
Philips Electronics North America Corporation recalled Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (se… - a moderate-severity action.
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (se… was recalled by Philips Electronics North America Corporation in April 12, 2017. Reason: Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audi…. Check the official notice for the remedy. Verify recall #Z-1707-2017 with the FDA Devices before acting.
The recall
Philips Electronics North America Corporation issued this moderate-severity FDA Devices recall-Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audi….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- April 12, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1707-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1707-2017) was formally reported on April 12, 2017, with the manufacturer initiating the action on March 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Electronics North America Corporation is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 2648.
The documented reason for this recall is: Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete] Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Swi…. 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
2648
Related Recalls
6
3 from same agency
Product description
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.
Reason for recall
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1707-2017 |
| Date reported | April 12, 2017 |
| Date initiated | March 6, 2017 |
| Recalling firm | Philips Electronics North America Corporation |
| Firm location | Andover, MA |
| Affected scope | 2648 |
| Distribution | Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kin… |
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-1707-2017) 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 MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.. Recalled by Philips Electronics North America Corporation. Units affected: 2648.
Why was this product recalled? ▼
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2017. Severity: Moderate. Recall number: Z-1707-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1707-2017) 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 April 12, 2017. 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.