Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
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 medical device recall involving a risk-of-harm product where patient data integrity could be compromised. No illnesses or injuries have been reported. Per the rubric, this meets the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System is subject to an FDA Class II recall. Approximately 399 units have been distributed worldwide. The issue affects software versions V6.0.0, V6.2.3 (released July 2, 2015), and V7.0.0 (released October 2, 2017).
The system may assign duplicate Unique Identifiers (UIDs) to exam files. If a DICOM-receiving system, such as a Picture Archiving and Communication System (PACS), relies solely on the UID to identify exams, the presence of duplicate identifiers could cause patient identification to become mismatched with the corresponding physiological data.
Facilities using the affected electrocardiograph systems should contact Baxter Healthcare Corporation regarding this issue.
The recalled product
- Product
- Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 399
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 V6.2.3
- Release Date 02-Jul-2015
- Software Version V7.0.0
- Release Date 02-Oct-2017 Units: 1) UDI/DI 00732094262957
- Serial Numbers: 118100617841
- 118250001722
- 118480000511
- 119140000676
- 119150000331
- 119180000544
- 119180000545
- 119180000546
- 119180000547
- 119180000548
- 119180000549
- 119180000550
- 119180000551
- 119340002011
- 119340002012
- 119460000996
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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