Device product
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
Z-2638-2026
Product summary
- Event
- Event 98833
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-2638-2026
Official wording
Reason: The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
Code information: Lot Code: Product Code: 1739994 UDI-DI: 00887761972780 Serial Numbers: 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694
Distribution pattern: Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.
Derived failure modes
-
Unknown
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.