Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect
Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.
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 hazard involves a software defect that may lead to intermittent data display during procedures, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Laboratories Inc. (St Jude Medical) is recalling 317 units of TactiSys Quartz Equipment operating on Software Version 1.7.0. The affected equipment includes Model PN-004 400 with specific part numbers and serial numbers listed in the recall documentation. The devices were distributed to facilities in the United States and numerous international locations, including the United Kingdom, Canada, Australia, and various countries in Europe, Asia, and the Middle East.
The recall is due to a defect where the device log fills the allocated disk space, preventing the storage of new log data. This issue may lead to intermittent contact force data being displayed during procedures. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Abbott Laboratories Inc. (St Jude Medical) for instructions on how to address the software defect. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
- Manufacturer
- Abbott Laboratories Inc. (St Jude Medical)
- Affected units
- 317
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)
- UDI: 07640157990194 Serial Numbers: 33019
- 33059
- 33350
- 33354
- 33357
- 33360
- 33361
- 33363
- 33390
- 33392
- 33393
- 33405
- 33417
- 33421
- 33444
- 33449
- 33451
- 33457
- 33458
- 33461
Distribution
Distribution scope not specified by the agency.
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