Operating Table System
Check against the official notice below — it lists the full affected range.
Getinge Group Logistics America, LLC is recalling 4,288 operating table systems due to a potential for hydraulic leakage at the inclination function. This leakage could cause the table top to move unexpectedly in a Trendelenburg or anti-Trendelenburg position, depending on how the patient is positioned. If this occurs, the patient may need to be transferred to a different operating room table, which could delay the surgical procedure.
The recalled tables were distributed domestically across all 50 states and internationally to numerous countries. The affected units can be identified by their part numbers (118001A0 through 118001D0) and corresponding UDI and serial numbers listed in the recall documentation. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.
Reason for recall: There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure. Distribution: Domestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Ger Quantity: 4288 units Lot/code info: Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.