WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss
WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.
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: This is a Class II medical device recall involving a software error that could affect device functionality. No illnesses or injuries have been reported. The recall qualifies as a risk-of-harm product without reported injury, meeting the High severity criterion.
Plain-English summary
WorkMate Claris v.1.2 Upgrade Kits (Model Numbers H800007 and H800012) manufactured by Abbott Laboratories Inc. (St Jude Medical) have been recalled due to a software error. The recall affects 8 units that were distributed to healthcare facilities in Michigan, Kansas, Missouri, and Texas.
The software error can cause the system to lose functionality or the screen to turn black during operation. This malfunction could affect the proper operation of the medical device.
Healthcare facilities that have received these upgrade kits should discontinue use of the affected models. Contact Abbott Laboratories or the FDA for instructions regarding replacement or repair options. As of the recall notice, no illnesses or injuries have been reported associated with this software error.
The recalled product
- Product
- WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
- Manufacturer
- Abbott Laboratories Inc. (St Jude Medical)
- Category
- Medical Device
- Affected units
- 8
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 (1)
- None
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Laboratories Inc. (St Jude Medical) 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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