Z-2696-2020Class II

IntelliVue MX800 patient monitor, model no. 865240

Name: Z-2696-2020 IntelliVue MX800 patient monitor, model no. 865240
Creator: Philips North America, LLC
Published: 2020-06-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-06-30 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of IntelliVue MX800 patient monitor, model no. 865240 on 2020-06-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2696-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-07-23
Terminated: 2024-01-25
Recalling firm: Philips North America LLC
Product: IntelliVue MX800 patient monitor, model no. 865240
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 30, 2020, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were instructed to always ensure that the monitor is grounded during operation with mains power. Affected products should be removed from use until the power supply of the monitor has been replaced. Philips Customer Service will contact customers when a replacement power supply is ready for installation. Philips expects all replacements to be complete within six months. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- 722-9377.
Quantity in commerce: 28
Distribution: Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
Product codes and lots: Serial numbers DE50887321 DE50887434 DE50887128 DE50887025 DE50887196 DE50887429 DE50887125 DE50887043 DE50887303 DE50887420 DE50887106 DE50887164 DE50887322 DE50887607 DE50887061 DE50887179 DE50887425 DE50887427 DE50887142 DE50887446 DE50887152 DE50887064 DE50887445 DE50887137 DE50887063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2696-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2696-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2697-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23

Product code MHX

K150310Class IIIntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH / cleared 2015-05-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)