Anspach Effort eMax2 Plus Console Recalled for Missing Service Interval
The Anspach Effort, Inc. is recalling 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.
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 an FDA Class II recall involving a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 439 units of the eMax2 Plus Console, an electric system. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to September 27, 2016, identified by DFU 18-0085 and Part No. SC2100.
Consumers and healthcare facilities should contact The Anspach Effort, Inc. for instructions on how to obtain the correct service interval information or a replacement document.
The recalled product
- Product
- Console, eMax2 Plus Product Usage: Electric system
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Electric System
- Hazard
- Affected units
- 439
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)
- All product shipped prior to 09/27/2016
- DFU 18-0085
- Part No. SC2100.
Distribution
Part of a larger recall action
This product is one of 103 recalled by The Anspach Effort, 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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