XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A
FDA device recall Z-0706-2024 · posted 2024-01-10 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 2985 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, Ang
- Date initiated
- 2023-12-08
- Date posted
- 2024-01-10
- Location
- Deerfield, IL
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