Reported Nov 13, 2024 · Ongoing
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
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 HScribe Holter System; ambulatory monitoring
- Lot codes and dates
- Software Versions
Software Version V4.0.0 V4.34release date 26-Oct-2005Software Version V6.1.0 V6.4.1
- release date 02-Aug-2016 Units1) UDI/DI 00732094263992
- Serial Numbers
1194700022802) UDI/DI 00732094264043
- Serial Numbers
1123201277841135001866601143002222721153502701641164905412661173605849251174405926231174405926241174405926251175106020231183300001381181806343041184800004693) UDI/DI 00732094264074
- Serial Numbers
113240166856114070193758118060610823118130624139118130624138118110619525118110619527118110619528118110619526118200638074120070000189120070000190120070000191120070000192120070000193211200700001931204200021161204200021171204200021181204200021191204200021201204600006761204600006771204600006781204600006791204600006801220900011901222000018204) UDI/DI 00732094264111
- Serial Numbers
1174906001945) UDI/DI 00732094296297
- Serial Numbers
118390000385UNKNOWN11183900003861194200017091194200017101194200017111194200017121194200017131194200017141194200017156) UDI/DI 00817655020112
- Serial Numbers
1155002837841164005294971164005309021165105453191170605539321172105700721172405735321172805782791173005804701173205826141180706122851181106193481180806150021155002842891164805401531182200000111182006370111190500001621191700005771192100017141194000016071194700003131200900008351210500007821210600007191214000003147) UDI/DI 00817655020129
- Serial Numbers
116400529498116400529499116400529500116400529501116400529502116400529503116520545635117020550528117120556670117190568282117210570495117370585793117370585791117370585792117390588072117510602159118270000671118340000888118370001918IBE-6AA-AXXXB1192000018211192400007371192800009981193400020481193900012661194900014031195000009001203100013861222500006698) UDI/DI 00817655020228
- Serial Numbers
133 of 133 codes
11731058168111809061716511811062102911813062438211815062749111816063055611640053026411718056657411727057749411727057749511725057558711737058625711740058893511746059544711748059760811809061716611810061789911818063418011824000106411827000034911828000125511828000125611829000086611831000119811835000119511837000076911837000077011908000140411913000133211917000062811918000103211921000172611924000100811924000119911927000010311927000054611945000081411947000053911947000054011951000167211951000167312002000104312008000059512009000059612009000059712011000054912014000104012020000012612031000142712032000069212033000028912013000037712050000071712052000019512052000019612101000036912101000037012103000110521121010000369121070000806
- Serial Numbers
189 of 189 codes
118120622023118120622022110490066007114400231139114460236305115050243715116430534192116430534193117400588939117460595452118180634590118250002188118280001249118290000002118290000003118310000690118310000691118310000692118310000693118310000694118310000695118310000696118340000899118520000583119060001356119090000896119150000330119180001176119270000092119450001895119450001896120120000571120190000066120190000067120190000068120190000069120190000070120190000071120190000072120260001471120410000422121050000796121060001456121060001457121080001844121080001845121080001846HSCRIBE-RECOVERY-5HSCRIBE-RECOVERY-6121220000167121220000168121230000652121280000779121280000780121310001053121310001054121330000559121330000560121400000319121430000526
- Serial Numbers
11644053569511) UDI/DI 00817655021744
- Serial Numbers
78 of 78 codes
112380133932116420532941116420532942117080554674117170565221117170565222117170565223117170565224117170565225117170565226117170565227117170565228117380586935117460594758117460594759117460595838117490599035117490599036117490599037117490599038117490599039117490599040117490599041118050610027118100617236118450001277118450001278118450001279118450001280118450001281118450001282118450001283118450001284118450001285118450001286119300001269119300001270119300001271119300001272119300001273119300001274119300001275119300001276119300001277119300001278119320000898120100002186120100002187120100002188120100002189120100002190121200000828121200000829121200000830121200000831121200000832121410001289121410001290121410001291121410001292
- Serial Numbers
11238013341811327016935911410019653511421021329111433022501511448023757411521025690711531026646211613038298211746059475211746059475311746059475411746059475511746059475611746059475711816062985411916000003511917000042411939000127911947000190212002000054912004000037912004000103312009000059412035000033912109000016912110000048112122000016612127000024112137000046212147000031612215000115312222000061112225000066812238000203612241000083812248000208112301000111012301000111110081765502216100m) None
- Serial Numbers
110460064411111420097209111490102308110110037447110110037902110130040679110130040386110260052782110300055017110460064409110490065972110490065973110480065644110510067535111030070004111080072938111130075520111130075528111160078026111170078940111160078346111180079818111190080488111190080489111240084631111270086586111280086683111320089454111330090406111400095714111400096095111410096343111410096868111420097208111480101785111490102298111500103121112020106107112010105069112100110612112120111947112370132376112480143987112200117405110160042488110160042628110440063372110490065751110500066872111280086684117330583137
- Software Versions
- Amount recalled
- 599 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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