Recall Z-0707-2024
Baxter Healthcare Corporation · initiated December 8, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
Codes / lots: 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…
Reason for recall
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
FDA-determined cause: Software design
Action taken
Baxter issued an Urgent Medical Device Correction notice to its consignees on 12/08/2023 via USPS first class mail. The notice explained the problem, hazard involved, requested the following actions be taken until a software update becomes available: - Clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing and provided the method for disabling the setting. - If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them, informing them of the requirement to evaluate the potential impact of the SCF during stress testing. - Respond using the customer portal: https://BaxterFieldActionCustomerPortal.onprocess.com. - If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. - If you purchased this product from a distributor, please note that the Baxter reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to your distributor/wholesaler according to their instructions. For general questions regarding this communication, contact Baxter (legacy Welch Allyn and Hillrom) Customer Service at 800-535-6663, Option 1, or Option 2 for Technical Support, between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday.
Details
- Recall number
- Z-0707-2024
- Initiated
- December 8, 2023
- Posted by FDA
- January 10, 2024
- Product code
- DPS – Electrocardiograph
- Quantity
- 1675 units
- 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…
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0705-2024 Class II | Q-Stress Cardiac Stress Testing System, version 6, with below product name / product…Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF)… | 12/08/2023Open, Classified |
| Z-0706-2024 Class II | XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)…Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF)… | 12/08/2023Open, Classified |