Baxter Healthcare Corporation: 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-DXXX

Hazard

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Details from the source

Reason for recall: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Distribution: United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jorda Quantity: 2985 units Lot/code info: Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None, Serial Numbers: 110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242, 111340091243, 111360092140, 111360092141, 111360092142, 111360092143, 111360092144, 111340091246, 111340091247, 111340091248, 111340091249, 111340091250, 111420097839, 111420097840, 111420097841, 111420097842, 111420097843, 111500103083, 111500103084, 111500103085, 111500103086, 111530104948, 111530104949, 111530104950, 111530104951, 112020106363, 112020106364, 112020106365, 112020106366, 112020106367, 112020106368, 112020106369, 112020106370, 112180115629, 112180115630, 112180115631, 1121801156

UPC codes

110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.