The Recall Desk
HighFDA (Devices)·Z-1855-2021·Announced 2021-06-23

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.

What this means for you

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
Hazard
  • software-error
  • device-malfunction

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

Distributed nationwide across the United States.

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