DigitalDiagnost 4 systems recalled over ceiling carriages hard to move
Philips is recalling 12 DigitalDiagnost 4 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record describes extra force needed to move a component, without stating a health consequence or reported harm.
Plain-English summary
The Philips DigitalDiagnost 4, in High Performance (model 712031) and Flex/Value (model 712032) configurations, is being recalled.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically, requiring additional force or physical exertion for manual movement, due to potential manufacturing issues.
The recall covers 12 units, including UDI-DI 00884838065321, distributed worldwide including nationwide in the United States and to countries including Australia and Austria. The FDA has classified the action as Class II.
The enforcement record describes the additional force required without stating a health consequence, and reports no injuries. Sites operating an affected system should follow Philips' instructions.
The recalled product
- Product
- DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
- Manufacturer
- Philips Medical Systems DMC GmbH
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Philips Medical Systems DMC GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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