← FDA ENFORCEMENT
Z-0465-2026Class II

Philips Medical Systems DMC GmbH

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Philips Medical Systems DMC GmbH
Product type
Device
Status
Ongoing
Report date
2025-11-19
Distribution
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.,
Product quantity
223 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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.

Product description

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

Code / lot 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;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →