—#182126

Product

IntelliVue MX800 patient monitor, model no. 865240

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K150310
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.

Timeline

Recall initiated: 2020-06-30
Terminated: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.