Philips North America, LLC: The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.

Recall number

Z-0926-2022

Recalling firm

Philips North America, LLC

Product

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.

Status

Open, Classified

Initiated

2022-02-07

Posted

not on file

Terminated

not on file

Reason

Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.

Root cause

Device Design

Action

The firm, Philips, issued "URGENT Medical Device Recall" Customer notification letters on 07 Feb 2022 via certified mail. Actions planned by the firm: An IFU addendum (part# 453564978601) was created that provides updated instructions for cleaning, disinfection, and sterilization. This addendum is to be downloaded www.philips.com/ifu and kept with the main IFU (part# 453564635891). Customer should take the following actions to prevent risk to patients or users: Prepare and soak in an enzymatic solution (detergent) to remove any debris prior to disinfection or sterilization. To reduce risk of cross-infection always clean all probes before applying to a different patient. Esophageal/Rectal Probes must be cleaned and sterilized between patient use. Skin probes can be cleaned and disinfected or cleaned and sterilized between patient use. Contact Philips Customer Services with questions. US customers: 1 (800) 722-9377, Worldwide customers: Contact local Philips representative.

Quantity

478,931 units

Distribution

Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burundi, Cambodia, Canada, Chile, China, Columbia, Congo (Democratic Republic of the), Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Japan, Jordan, Kazakhstan, Korea Republic of, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Mauritius, Mayotte, Mexico, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Lucia, Saint Pierre and Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Swaziland, Sweden, Switzerland, Syrian and Republic, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen and Zambia.

Lot, serial or model codes

All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A (01)00884838000995, model 21076A (01)00884838001008, model 21078A (01)00884838001015, model 989803162621 (01)00884838008045, model 989803162631 (01)00884838008052, and model 989803162641 (01) 00884838008069

510(k) numbers

["K962070"]

PMA numbers

not on file

Product code

FFL

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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