Reported Nov 13, 2024 · Ongoing
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
- Lot codes and dates
- Software VersionsSoftware Version V6.1.0 - V6.4.1
- Release Date 02-Aug-2016 Units1) UDI/DI 00732094261301
- Serial Numbers
1164005295261164105315951164205319291164205323941164405349581164405349591164405349601165005430681165105441881165105441921165105441912) UDI/DI 00812345027051
- Serial Numbers
159 of 159 codes
116410531060117210570806115240259136115350270162115530286838116130382969116410531059117010548786117160563990118090615607118130624377115260260785115310266618115280263535115370271720115390273747115390273748115410276165115430277859115460280004116050290951116100343595116110348130116110348131116170409317116220446115116330522729116330523086116350524579116350524580116350524581116350524582116350524853116420531720116430533397116430533398116440535530116350524071116490541748116490541749117250575051117250575363117250575364117340583722117410590078117430592084117500601366118090616236118160629028118140625595118160629029118330000135118410000001118410000002118460000097118480000460118480000461118480000462118490001240119020000445
- Serial Numbers
201 of 201 codes
115110248137115120250168115120250169115120250835115300266105115320267445115350270310115390274014115410276436115430277751116030288867116050291028116100343594116160400312116170411681116270498880116270498881116290510913116310521392116330522476116330522846116360525666116380527662116380527663116380527664116380527665116380527666116380527667116400529602116420532353116510544289116510545147116510545159116510545158117140561179117150562724117160564171117160564172117170566155117180566532117180566934117190568193117250575344117310581639117310581640117310581638117310581641117310581642117440593357117490599735117490599734117500600817117500600819117500600818117490599736117510602844118200638054118190635525118190635527118180633949
- Serial Numbers
343 of 343 codes
115110249707115110249708115130251591115130251592115130251593115130251594115130251595115130251596115130251597115130251598115130251599115130251600115130251601115150252703115210257523115210257512115220257782115280264212115300265573115300265777115310266138115310266124115310266216115310266655115320268102115370271878115410275610115420277047115440278420115510285228115500284465116040288873116030288807116050290952116060301719116070309917116090323664116090330859116120374781116130382238116130383028116170408045116170411682116200435246116210440263116240477780116290511737116310521391116330522847116350525036116350525037116360525872116360526094116410531590116420532605116430533949116440535188116440535278116440535279116450535997
- Serial Numbers
292 of 292 codes
115140252371115180255199115200256450115200256484115170254607115240259273115270262436115270262455115270262556115280264204115280264328115440278240115390274074115500283203115490282596115520286030115500283938115510285075116030288752116040289702116050290280116100346578116110349503116110361053116120364554116130376068116160401959116170409316116170411679116190428778116190431104116230449929116260495851116330522475116340523672116360526095116370527085116400530262116410531591116430533997116440535238116440535239116450536627116450536638116460538289116460538288116470539397116470539537116470539536116470539538116490541861116510544316116510544315116510545146116520545930116520545583116530547264116520545584116520546523116520546524
- Amount recalled
- 1003 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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