Siemens Vista Air Compressor Recalled for Fire and Shock Hazards
Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.
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 recall involves a risk of fire and electrical shock, which constitutes a significant injury hazard under the rubric for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling four Vista Air Compressors used in the Dimension Vista 500 and Dimension Vista 1500 in vitro diagnostic systems. The recall is due to a manufacturing defect where a small number of the units were miswired.
If the affected compressors are installed and powered up, the miswiring could cause a fire or become an electrical shock hazard. The affected units are identified by Siemens Material Numbers (SMN) 10284473, 10488224, 10444801, and 10444802, with serial numbers 0913900306 and 0913900355.
The recalled products were distributed worldwide, with specific US distribution to Illinois, Ohio, and Tennessee, and international distribution to Italy. Users should stop using the affected air compressors immediately and contact Siemens Healthcare Diagnostics for instructions on repair or replacement.
The recalled product
- Product
- Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 4
Distribution
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