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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliVue MX800

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  Class 2 Device Recall IntelliVue MX800 see related information
Date Initiated by Firm June 30, 2020
Create Date July 23, 2020
Recall Status1 Terminated 3 on January 25, 2024
Recall Number Z-2696-2020
Recall Event ID 85908
510(K)Number K150310  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product IntelliVue MX800 patient monitor, model no. 865240
Code Information 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  
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
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