Cardiac stress testing system recalled due to duplicate patient identifiers
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
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 with no reported illnesses or injuries. The hazard involves potential patient identification mismatches in cardiac stress testing data, which represents a risk of harm to patients. This falls into the High severity category per the rubric's criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System is being recalled due to a potential for exam files to be assigned duplicate Unique Identifiers (UIDs). These identifiers are used to distinguish individual examination records. If a receiving system, such as a Picture Archiving and Communication System (PACS), relies solely on the UID to validate and accept exams, the duplicate identification could cause patient identification information to become mismatched with cardiac stress test physiological data.
A mismatch could result in cardiac test results being incorrectly associated with the wrong patient's medical record. This could lead to clinical errors if healthcare providers rely on the misidentified data for diagnosis or treatment decisions.
Approximately 2,461 units with specific software versions are affected. The units have been distributed worldwide. Healthcare facilities operating these systems should be aware of this potential issue and evaluate whether their receiving systems have safeguards beyond UID verification to prevent patient identification mismatches.
The recalled product
- Product
- Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2,461
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)
- Software Versions: Software Version V6.0.0 V6.3.2
- Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094263213
- Serial Numbers: 117240573990
- 117360584950
- 2) UDI/DI 00732094263237
- Serial Numbers: 117500600524
- 122410000834
- 3) UDI/DI 00732094263336
- Serial Numbers: 118110620686
- 4) UDI/DI 00732094263374
- Serial Numbers: 116520545398
- 116520545399
- 117050553501
- 117050553502
- 117170565092
- 117170565093
- 117170565094
- 117170565095
- 117170565096
- 118090616242
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corporation 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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