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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

Z-0464-2026

October 01, 2025

Class II

Product summary

Firm
Philips Medical Systems DMC GmbH
Event
Event 97748
Status
Ongoing
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-0464-2026

Official wording

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.

Code information: 1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343;

Distribution pattern: 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.,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.