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Philips Medical Systems DMC GmbH: DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

Medical DevicesSource: FDA (device) · Date: 2025-11-19

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Medical Systems DMC GmbH
Product
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Reason / hazard
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
Recall initiated
2025-10-01
Code info
1. Model Number: 712034; UDI-DI: 00884838090699; Serial Numbers: 22860392, 22860404, 22860437, 22860556, 22860559, 22860578, 22860581, 22860583, 22860584, 23860409, 23860424, 23860428, 23860607, 23860625, 23860632, 23860652, 23860656, 23860658, 23860665, 23860667, 23860668, 23860669, 23860680, 23860684, 23860693, 23860700, 23860717, 23860769, 23860780, 23860812, 23860820, 23860823, 23860824, 24860041, 24860042, 24860043, 24861002, 24861010, 24861018, 24861020, 24861021, 24861031, 24861036, 24861039, 24861040, 24861041, 24861042, 24861055, 24861063, 24861072, 24861076, 24861083, 24861086, 24861088, 24861091, 24861105, 24861106, 24861107, 24861108, 24861110, 24861112, 24861114, 24861118, 24861121, 24861123, 24861124, 24861125, 24861126, 24861128, 24861130, 24861132, 24861133, 24861135, 24861136, 24861137, 24861138, 24861140, 24861141, 24861142, 24861143, 24861150, 24861153, 24861155, 24861160, 24861162, 24861165, 24861175, 24861203, 24861206, 24861207, 24861208, 24861216, 24861225, 24861226, 24861233, 24861234, 24861237, 24861238, 24861239, 24861240, 24861241, 24861242, 24861243, 24861245, 24861254, 24861255, 24861256, 24861257, 24861258, 24861259, 24861261, 24861262, 24861263, 24861264, 24861265, 24861268, 24861269, 24861271, 24861285, 24861286, 24861290, 24861291, 24861294, 24861295, 24861297, 24861298, 24861299, 24861300, 24861301, 24861305, 24861308, 24861314, 24861317, 24861318, 24861319, 24861320, 24861321, 24861324, 24861326, 24861327, 24861328, 24861329, 24861331, 24861340, 24861341, 24861342, 24861343, 24861344, 24861346, 24861352, 24861360, 24861361, 24861362, 24861363, 24861364, 24861365, 24861366, 24861367, 24861369, 24861370, 24861372, 24861373, 24861378, 24861381, 24861382, 24861385, 24861386, 24861387, 24861388, 24861389, 24861391, 24861397, 24861398, 24861399, 24861400, 24861401, 24861404, 24861405, 24861407, 24861408, 24861410, 24861411, 24861412, 24861413, 24861414, 24861418, 24861419, 24861420, 24861421, 24861423, 24861424, 24861428, 24861429, 24861435, 24861436, 24861438, 24861439, 24861440, 24861441, 24861442, 24861443, 24861446, 24861450, 24861451, 24861455, 24861456, 24861459, 24861460, 22860131; 2. Model Number: 712035; UDI-DI: 00884838090705; Serial Numbers: 23860438, 24861021, 24861023, 24861037, 24861044, 24861045, 24861046, 24861047, 24861054, 24861055, 24861061, 24861062, 24861063, 24861064;
Product quantity
223 units
Voluntary mandated
Voluntary: Firm initiated
City
Hamburg
Country
Germany
Event id
97748
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