FDAClass IIJuly 29, 2020

IntelliVue MX800 patient monitor recall

IntelliVue MX800 patient monitor, model no. 865240

Why was IntelliVue MX800 patient monitor 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
IntelliVue MX800 patient monitor, model no. 865240
Recalling firm
Philips North America, LLC
Quantity
28
Distribution
Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
Recall date
July 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls