CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
IntelliVue MX700 patient monitor recalled by Philips North America
Philips North America is recalling IntelliVue MX700 patient monitor, distributed in California, Hawaii, Massachusetts, New York, Utah. The recall was initiated on 30 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2697-2020
- FDA event ID
- 85908
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2020
- FDA classified
- 23 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Patient Monitors
Timeline
| 30 Jun 2020 | Recall initiated by company | |
| 23 Jul 2020 | Classified by FDA | +23 days |
| 29 Jul 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
IntelliVue MX700 patient monitor, model no. 865241
Where it was distributed
Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
Questions about this recall
Why was it recalled?
Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.
Which lots are affected?
Serial numbers DE58562415 DE58562344 DE58562353
Where was it sold?
Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85908This product is part of a recall event; the main page for the event is IntelliVue MX800 patient monitor recalled by Philips North America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IntelliVue MX800 patient monitor recalled by Philips North America | Philips North America | Foreign Material | 5 states |
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