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Recall Observatory FDA recall evidence

Device product

Operating Table System

Z-1296-2021

February 11, 2021

Class II

Product summary

Firm
Getinge Group Logistics America, LLC
Event
Event 87386
Status
Ongoing
Classification
Class II
Quantity
4288 units
Official record key
device-enforcement:Z-1296-2021

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: 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, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Lybia, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom, Uzbekistan, Venezuela, Vietnam and Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.