SurgiCount+ System software error bypasses sponge tracking alerts
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
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 an FDA Class II recall affecting a critical safety function of a medical device. The error creates a risk of retained surgical items with no reported injuries to date. Per the rubric, this risk-of-harm scenario without documented patient harm scores at High (3).
Plain-English summary
Stryker Instruments' SurgiCount+ System Application, Software Version 2.0.17 (Catalog Number 0694-002-090) is being recalled due to a software error that may compromise sponge tracking during surgical procedures.
When scanning sponges after a surgical procedure, the system may incorrectly allow a sponge to be counted twice without generating the required prompt to document the discrepancy. This error could allow a surgical case to be closed without verification that all sponges have been properly tracked and accounted for.
The recall affects 44 units distributed to Kansas and Maine. A software update is available from the manufacturer to prevent this error.
The recalled product
- Product
- SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 44
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)
- UDI-DI (GTIN): 07613327543094
Distribution
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