The Recall Desk
ModerateFDA (Devices)·Z-1615-2015·Announced 2015-05-20

Siemens Dimension Chemistry Systems Recalled for Non-Standard Power Plugs

Siemens Healthcare Diagnostics is recalling certain Dimension Integrated Chemistry Systems installed with non-standard power plugs due to a potential electrical hazard.

What this means for you

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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The source explicitly states that the likelihood of injury is extremely low, and no injuries or illnesses are reported, fitting the criteria for a moderate risk of harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling certain Dimension Integrated Chemistry Systems, including the Dimension EXL, RxL, and Xpand series. The recall involves 17,801 units that were distributed in Japan. These systems are discrete, random-access, microprocessor-controlled instruments used for in vitro diagnostic testing of body fluids.

The recall is being issued because certain instrument power configurations may have been installed with a non-standard instrument power plug. The use of this non-standard plug configuration may lead to a potential electrical hazard. The source text notes that the likelihood of potential clinical impact or injury due to this issue is extremely low.

Affected units are identified by specific model and material numbers, including Model numbers D045912, D193440, and D140066, and Material numbers 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, and 10444838. Users should check their equipment for these identifiers and contact the manufacturer for further instructions.

The recalled product

Product
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access
Affected units
17,801

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 (13)

  • Model numbers: D045912
  • D193440
  • D140066
  • Material Numbers: 10472176
  • 10636928
  • 10465412
  • 10461038
  • 10444828
  • 10444829
  • 10461849
  • 10461043
  • 10444837
  • 10444838

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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