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FDA (Device enforcement)Recalled 2022-04-25class ii

GE Healthcare, LLC: Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

Is my product affected?

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

  • UPC 00840682102322

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare is recalling backup batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019. The backup batteries in these devices can fail earlier than their estimated lifespan. Approximately 6,612 devices are affected by this recall, with distribution worldwide including the United States and numerous international countries. The devices are identified by Model Number 1009-9050-000 and specific serial numbers beginning with codes such as APKB, APKZ, APKY, and APKA.

The source document does not specify a remedy for affected consumers or what actions they should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Backup batteries can fail earlier than their estimated life.

Details from the source

Reason for recall: Backup batteries can fail earlier than their estimated life. Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Nepal, New Zealand, Nor Quantity: 6,612 devices Lot/code info: Model Number: 1009-9050-000; UDI/DI: 00840682102322; Serial Numbers: APKB00323, APKB00324, APKB00325, APKB00326, APKB00327, APKB00328, APKZ01002, APKB00236, APKB00237, APKB00238, APKB00239, APKB00240, APKA00595, APKA00596, APKA01159, APKB00159, APKB00241, APKB00242, APKB00243, APKB00244, APKB00245, APKB00246, APKB00247, APKB00248, APKB00249, APKB00250, APKB00308, APKB00309, APKY01153, APKY01219, APKY02040, APKY02041, APKY02401, APKY02402, APKY02403, APKY02404, APKY02405, APKY02406, APKY02407, APKY02408, APKY02409, APKY02410, APKY02411, APKY02412, APKY02413, APKY02414, APKY02415, APKY02416, APKY02417, APKY02418, APKY02419, APKY02420, APKY02421, APKY02422, APKY02423, APKY02424, APKY02425, APKY02426, APKY02427, APKY02428, APKY02429, APKY02430, APKY02431, APKY02432, APKY02433, APKY02434, APKY02435, APKY02436, APKY02437, APKY02438, APKY02439, APKY02440, APKY02441, APKY02442, APKY02443, APKY02444, APKY02445, APKY02446, APKY02447, APKY02448, APKY02449, APKY02450, APKY02451, APKY02452, APKY02453, APKY02454, APKY02455, APKY02456, APKY02457, APKY02458, APKY02459, APKY02460, APKY02461, APKZ00107, APKZ00108, APKZ00109, APKZ00110, APKZ00111, APKZ00112, APKZ00113, APKZ00516, APKZ00517, APKZ01733, APKZ01734, APKZ01735, APKZ01736, APKZ01437, APKZ00843, APKZ00844, APKZ00845, APKZ00846, APKZ00847, APKZ00848, APKZ00889, APKZ00890, APKZ00891, APKZ00892, APKZ00893, APKZ00894, APKA00876, APKA01882, APKA01883, APKA01884, APKY00920, APKB00257, APKB00258, APKB00259, APKB00260, APKB00261, APKB00262, A

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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