Stryker Neptune 3 Rover Recalled for Electromagnetic Interference Shutdowns
Stryker is voluntarily recalling 78 Neptune 3 Rover devices because electromagnetic interference may cause system errors and shutdowns.
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: This is a voluntary precautionary recall for a functional defect (shutdown due to interference) with no reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation has initiated a voluntary recall of the 120 V Neptune 3 Rover, Model Number 0703-001-000. The recall involves 78 units distributed domestically to Michigan, California, Idaho, and Iowa. No distribution to VA/DOD or foreign markets is reported.
The recall was initiated on July 1, 2016, due to a potential for the device to experience system errors that cause it to shut down if high levels of electromagnetic interference are present in the operating room. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Stryker for instructions on how to proceed with the recall and replacement or repair of the devices.
The recalled product
- Product
- 120 V Neptune 3 Rover, Model Number: 0703-001-000
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 78
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 (20)
- 120 V Neptune 3 Rover
- Model Number: 0703-001-000
- Serial Numbers: 1606300523
- 1610606263
- 1610903973
- 1610904293
- 1612303683
- 1612303823
- 1612303963
- 1606300553
- 1610606273
- 1610904063
- 1610904313
- 1612303703
- 1612303833
- 1612303973
- 1606300583
- 1610606303
- 1610904083
- 1610904343
Distribution
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