Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
FDA device recall Z-0321-2025 · posted 2024-11-07 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- Action taken
- Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/11/2024 via USPS First Class Mail. The notice explained the issue, potential hazard to the patient, and provided instructions for the to the system IT administrator to correct the issue which is already available in the current version of software.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 2461 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-10-11
- Date posted
- 2024-11-07
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (K152944) | Mortara Instrument, Inc. | 2016-01-06 |