Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 26, 2016
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwi
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Electronics North America Corporation recalled Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865… - a moderate-severity action.
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865… was recalled by Philips Electronics North America Corporation in October 26, 2016. Reason: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of EC…. Check the official notice for the remedy. Verify recall #Z-0293-2017 with the FDA Devices before acting.
The recall
Philips Electronics North America Corporation issued this moderate-severity FDA Devices recall-Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of EC….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- October 26, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0293-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0293-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on September 19, 2016. 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 2,212 units.
The documented reason for this recall is: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX Distribution data in the federal record shows the product reached: Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ir…. 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
2,212 units
Related Recalls
6
3 from same agency
Product description
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide SW Revisions: B.05.28, B.05.29, and B.05.32 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
Reason for recall
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0293-2017 |
| Date reported | October 26, 2016 |
| Date initiated | September 19, 2016 |
| Recalling firm | Philips Electronics North America Corporation |
| Firm location | Andover, MA |
| Affected scope | 2,212 units |
| Distribution | Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan… |
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-0293-2017) 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 MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide SW Revisions: B.05.28, B.05.29, and B.05.32 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. Recalled by Philips Electronics North America Corporation. Units affected: 2,212 units.
Why was this product recalled? ▼
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0293-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, 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-0293-2017) 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 October 26, 2016. 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.