Siemens Intevo Series Imaging Systems Recalled for Overheating Risk
Siemens Medical Solutions USA is recalling 185 Intevo Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classifies this as a Class II recall, and the hazard involves overheating of a power assembly, which poses a risk of fire or burn injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 185 Siemens Intevo Series radiological imaging systems. These systems combine single photon emission computed tomography (SPECT) and computed tomography (CT) cameras. The affected model numbers are 10764801, 10764802, 10764803, and 10764804.
The recall is due to fuses with improper amperage ratings installed in the systems. In conjunction with a specific failure mode of the Power Controller assembly, these fuses could lead to the overheating of the assembly. The agency classifies this as a Class II recall.
The affected units were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 185
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 (3)
- Model numbers: 10764801
- 10764802
- 10764803 and 10764804.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc. 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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