Reported Jan 17, 2024 · Ongoing
XScribe Cardiac Stress Testing System, version 6, with below product names and codes
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?
XScribe Cardiac Stress Testing System, version 6, with below product names and codes
72 of 72 products
| Model / number | Product as published |
|---|---|
XS6/RS6 | XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) |
XS6/RS6 | REVIEW WKSTN KIT, XR-6AC-BXXXX; b) |
XS6/RS6 | REVIEW WKSTN KIT, XR-6AC-DXXXX; c) |
XS6 | REVIEW WKSTN KIT, XR-6AC-XXXXX; d) |
XS6 | WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) |
XS6 | WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA; f) |
XS6 | WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) |
XS6 | WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA; h) |
XS6 | WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC; i) |
XS6 | WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA; j) |
XS6 | WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB; k) |
XS6 | WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB; l) |
XS6 | WAM TTL SYS AHA XML, XSCRIBE-6AA-BXAAA; m) |
XS6 | WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB; n) |
XS6 | WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX; o) |
XS6 | WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA; p) |
XS6 | WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB; q) |
XS6 | WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC; r) |
XS6 | WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX; s) |
XS6 | WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB; t) |
- Lot codes and dates
- Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None
- Serial Numbers
301 of 301 codes
110120039437110120039438110120039439110190044556110190044557110190044558110190044559110190044560110190044561110190044562110190044563110190044564110190044565110190044566110190044567110200045831110200045832110200045833110200045834110200045835110260052818110260052819110260052820110260052821110260052822110260052823110420061166110420061167110420061168110420061169110460064753110460064754110460064755110460064697110460064698110460064699110460064700110460064702110460064703110460064704110460064705110460064706111150077803111150077804111150077805111150077806111150077807111150077808111150077809111200081334111200081335111200081336111200081337111200081338111200081339111200081340111200081341111300088621111300088622111300088623
- Serial Numbers
158 of 158 codes
110120039425110120039426110120039427110190044568110190044569110190044570110200045836110200045837110200045838110330056675110330056676110370059009110370059010110370059011110390059824110420060941110420060942110500066898110500066899110500066900111060071714111060071715111060071716111150077462111150077463111200081342111200081343111270086404111270086405111270086406111270086407111380093553111380093554111380093555111380093556111380093557111470101214111470101215111500103087111500103088111500103089112030106627112030106628112050108028112050108029112100110764112100110765112050108026112050108027112220118711112220118712112220118713112270124286112270124287112270124288112320128032112320128033112320128034112410137135112410137136
- Serial Numbers
166 of 166 codes
110120039363110120039364110230049218110230049219110230049220110230049221110280053721110280053722110280053723110280053724110280053725110330056793110330056794110370059012110370059013110370059014110410060508110410060509110410060510110410060511110440063042110440063043110440063044110440063045110460064750110460064751110460064752110460064707110460064708110460064709110460064710110460064711110460064712110460064713110460064714111060071710111060071711111060071712111060071713111200081535111200081536111200081537111230083963111230083964111230083965111330090559111330090560111330090561111330090562111330090563111330090564111330090565111450099468111450099469111450099470111450099471111450099472111450099473111450099474111450099475
- Serial Numbers
110120039428110120039429110120039430110120039431110120039432110120039433110120039434110120039435110120039436e) 41000-030-60UDI/DI 00817655020051
- Serial Numbers
706 of 706 codes
118060611436118060611438118060611439118080615013118080615022118180634934118080615011118180634932118180634933118180634936118060611447118080615017118080615018118080615021118080615019118080615020118180634938118180634939118180634940118160628568118160628569118160628570118180634931118180634935118160628577118160628578118160628579118160628580118160628581118160628583118160628564118160628565118160628566118160628567118160628571118160628572118160628573118160628582118160628574118160628575118160628576118340001391118340001392118340001393118340001394118340001395118340001396118340001397118340001388118340001389118340001390119110000129119110000130119110000132119110000133119110000134119110000135119110000136119110000137119130001327
- Serial Numbers
289 of 289 codes
118160628584118160628585118320000033118330000323118330000325118320000032118330000324118330000326118330000320118330000321118330000322118450000081118450000082118330000319118470000102118470000406118470000407118470000408118480000446118480000447118480000448118480000449118500001826118500001827118500001834118500001835118500001828118500001830118500001829118500001831118500001832119190000641119190000642119190000638119190000639119190000640118500001825118500001833119250001407119320001005119320001006119320001007119320001002119320001003119320001004119350002522119350002523119350002524119350002525119430001320119430001321119430001322119430001323119430001318119430001319119470002142119470002144119470002146119470002143119470002145
- Serial Numbers
11949000044011950000133512135000104312007000073011949000043912007000073211838000302211838000302311847000010311847000010411950000133611838000302211838000302311847000010311847000010412007000073112315000206812315000206912315000207012316000055612315000205512320000166912315000205712315000205812320000167012320000167112315000206612315000206712007000073312315000205612315000206112315000206212315000206312315000206412315000206512315000205912315000206012316000055212316000055312316000055412316000055511950000133512135000104312007000073011949000043912007000073211732058200612007000073412007000073512007000073612007000073711847000104120070000738120070000739121350001044121350001045
- Amount recalled
- 2985 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
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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