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

Recall number

Z-0465-2026

Recalling firm

Philips Medical Systems DMC GmbH

Product

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

Status

Open, Classified

Initiated

2025-10-01

Posted

2025-11-07

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

On October 1, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use. It is recommended that customers use the motorized movement option until the technical solution has been implemented. The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative. B. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. C. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed. 5. Actions planned by Philips to correct the problem. Philips will provide the technical solution details when finalized. This notice has been reported to the appropriate Regulatory Agencies. If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM 8PM EST, Monday-Friday).

Quantity

223 units

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.,

Lot, serial or model codes

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;

510(k) numbers

["K202564"]

PMA numbers

not on file

Product code

MQB

Firm FEI

3003768251

Firm city

Hamburg

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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