Siemens MicroScan WalkAway Plus Instruments Recalled for Hinge Spring Failure
Siemens is recalling MicroScan WalkAway-40 and 96 plus instruments because springs in the access door hinge assembly are detaching, causing premature failure and potential safety issues.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a 'potential safety issue' due to mechanical failure but does not report any specific injuries, illnesses, or fatalities, aligning with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. The recall is due to springs contained in the access door hinge assembly becoming detached, which causes premature failure of the hinge assembly and presents a potential safety issue for customers.
The affected products were distributed worldwide, including in the United States and numerous other countries such as Canada, China, France, Germany, India, Japan, and the United Kingdom. The specific material and catalog numbers for the WalkAway 40 are 10444853 and B1018-283, respectively, while for the WalkAway 96 they are 1044854 and B1018-284.
Customers should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to address the defect. The source text does not specify a particular action such as stopping use or returning the product, but notes that some units have already been repaired.
The recalled product
- Product
- MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (4)
- WalkAway 40 - Material number: 10444853
- catalog number: B1018-283
- WalkAway 96 - Material number: 1044854
- Catalog number B1018-284.
Distribution
Distributed nationwide across the United States.
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