Cardiac stress testing system may assign duplicate exam identifiers to patients
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.
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 Class II FDA recall involves a theoretical data-integrity hazard with no reported adverse events or injuries. The risk is that duplicate identifiers could cause patient data mismatches if receiving systems rely solely on UIDs, but actual harm has not been documented, placing this at High severity (3) rather than Severe (4).
Plain-English summary
The Hillrom Welch Allyn XScribe Cardiac Stress Testing System is a programmable diagnostic computer used to conduct cardiac stress tests. Approximately 766 units of this system have been distributed worldwide.
The systems may assign duplicate Unique Identifiers (UIDs) to exam files. This could pose a problem if the receiving medical system (such as a Picture Archiving and Communication System, or PACS) relies solely on the UID to match exams to patient records, potentially resulting in mismatches between patient identification and their physiological test data.
This recall affects healthcare facilities and cardiac testing centers using the affected XScribe systems with software versions V6.0.0 or V6.3.2 released July 2, 2015.
The recalled product
- Product
- Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- duplicate-identifier
- patient-data-mismatch
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 00732094259032
- Serial Numbers: 115340269178
- 117060553883
- 117060553884
- 117060553885
- 119230003169
- 2) UDI/DI 00732094259070
- Serial Numbers: 117130559202
- 117130559203
- 117130559204
- 3) UDI/DI 00732094259100
- Serial Numbers: 116270497046
- 117190567440
- 4) UDI/DI 00732094259148
- Serial Numbers: 117350583961
- 119060000843
- 122090000529
- 5) UDI/DI 00732094259179
- Serial Numbers: 116240458434
Distribution
Distribution scope not specified by the agency.
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