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.
- Company
- Philips North America, Llc
- Recall Initiated
- February 7, 2022
- Recall Number
- Z-0926-2022
- Quantity
- 478,931 units
- Firm Location
- Andover, MA
Reason for Recall
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
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 / Code Info
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
Root Cause
Device Design
Action Taken
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.