FDA Medical devices recall ·
Hillrom Welch Allyn Vision Express Holter Analysis System recall
- Recall number
- Z-0323-2025
- Date
- (initiated October 11, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1003 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Versions: Software Version V6.1.0 - V6.4.1, Release Date 02-Aug-2016 Units: 1) UDI/DI 00732094261301, Serial Numbers: 116400529526, 116410531595, 116420531929, 116420532394, 116440534958, 116440534959, 116440534960, 116500543068, 116510544188, 116510544192, 116510544191; 2) UDI/DI 00812345027051, Serial Numbers: 116410531060, 117210570806, 115240259136, 115350270162, 115530286838, 116130382969, 116410531059, 117010548786, 117160563990, 118090615607, 118130624377, 115260260785, 115310266618, 115280263535, 115370271720, 115390273747, 115390273748, 115410276165, 115430277859, 115460280004, 116050290951, 116100343595, 116110348130, 116110348131, 116170409317, 116220446115, 116330522729, 116330523086, 116350524579, 116350524580, 116350524581, 116350524582, 116350524853, 116420531720, 116430533397, 116430533398, 116440535530, 116350524071, 116490541748, 116490541749, 117250575051, 117250575363, 117250575364, 117340583722, 117410590078, 117430592084, 117500601366, 118090616236, 118160629028, 118140625595, 118160629029, 118330000135, 118410000001, 118410000002, 118460000097, 118480000460, 118480000461, 118480000462, 118490001240, 119020000445, 119020000446, 119060000053, 119060000054, 119070001052, 119070001053, 119230002856, 119340000158, 119370000057, 119370000058, 119370000178, 119370001496, 119370001497, 119370001498, 119460000833, 119500001339, 120020000988, 120100000089, 120280000432, 120320001228, 120440000892, 120510002432, 121100000101, 121110000861, 121110000862, 1
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0323-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.