FDA-Device2026-07-08Class II
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
Hazard
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.
Sold states
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.
Affected count
13 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2638-2026More Baxter Healthcare Corporation recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
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