Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the
Check against the official notice below — it lists the full affected range.
Spacelabs Healthcare, Ltd. has recalled 328 units of the Arkon Anesthesia Delivery System with Arkon Software Version 2.70 and Display Unit Assembly 650-1769-00 (Model #99999), which includes a ventilator. The system may enter a failed state in which mechanical ventilation ceases while the machine is in use or while idle. The affected units have been distributed worldwide to numerous U.S. states including Louisiana, Nebraska, Colorado, Wyoming, Montana, New Mexico, Indiana, Maine, New York, Illinois, Massachusetts, Texas, Pennsylvania, and Puerto Rico, as well as to countries including Peru, Bolivia, Panama, Malaysia, Poland, Ireland, Morocco, Mexico, Canada, the United Kingdom, France, China, and Ecuador.
The recall involves specific serial numbers ranging from ARKN-000003 through ARKN-000445 and a UDI number of 10841522100017. The source document does not specify a remedy or corrective action for consumers who possess affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Reason for recall: Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. Distribution: Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR. Quantity: 328 Lot/code info: UDI #: 10841522100017, Serial #: ARKN-000014 ARKN-000045 ARKN-000117 arkn-000248 ARKN-000003 ARKN-000004 ARKN-000012 ARKN-000013 ARKN-000039 ARKN-000040 ARKN-000044 ARKN-000047 ARKN-000048 ARKN-000049 ARKN-000259 ARKN-000260 ARKN-000334 ARKN-000425 arkn-000318 arkn-000321 ARKN-000120 ARKN-000380 ARKN-000381 ARKN-000382 ARKN-000383 ARKN-000384 ARKN-000385 ARKN-000386 arkn-000263 arkn-000264 ARKN-000288 arkn-000320 arkn-000231 arkn-000232 ARKN-000250 ARKN-000251 ARKN-000252 ARKN-000445 ARKN-000190 ARKN-000191 ARKN-000192 ARKN-000193 ARKN-000194 ARKN-000208 ARKN-000051 ARKN-000054 ARKN-000056 ARKN-000057 ARKN-000058 ARKN-000059 ARKN-000060 ARKN-000061 ARKN-000063 ARKN-000064 ARKN-000112 ARKN-000114 ARKN-000116 ARKN-000171 arkn-000242 arkn-000243 arkn-000244 ARKN-000062 ARKN-000071 ARKN-000072 ARKN-000073 ARKN-000074 ARKN-000075 ARKN-000076 ARKN-000077 ARKN-000078 ARKN-000037 ARKN-000066 ARKN-000067 ARKN-000132 ARKN-000133 ARKN-000134 ARKN-000144 ARKN-000186 ARKN-000187 ARKN-000188 ARKN-000189 ARKN-000196 ARKN-000197 ARKN-000198 ARKN-000199 ARKN-000200 ARKN-000201 ARKN-000202 ARKN-000203 ARKN-000204 ARKN-000205 ARKN-000206 ARKN-000207 ARKN-000209 ARKN-000210 ARKN-000211 ARKN-000212 ARKN-000213 ARKN-000214 ARKN-000215 ARKN-000216 ARKN-000217 ARKN-000220 ARKN-000221 ARKN-000222 arkn-000254 arkn-000261 ARKN-000262 ARKN-000278 ARKN-000279 ARKN-000283 ARKN-000286 ARKN-000294 ARKN-000300 ARKN-000301 ARKN-000302 ARKN-000303 ARKN-000304 ARKN-000305 arkn-000322 arkn-000323 arkn-000324 ark
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.