Cardiology records system recalled over data saved to the wrong patient
Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: test results attached to the wrong patient record can misdirect clinical decisions, and no injuries are reported.
Plain-English summary
The Spacelabs Sentinel V11 Cardiology Information Management System, catalog number 92810, software version 11.6.0, is being recalled.
The firm describes two distinct issues. During patient admission, patient demographic fields may default to those of a previously viewed patient. And on systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record.
The recall covers 142 units carrying UDI-DI 10841522125751, distributed in Minnesota and internationally including Canada, Germany, France, the United Kingdom and Italy. The FDA has classified the action as Class II.
Misattributed cardiac test data can inform decisions about the wrong person. Sites running version 11.6.0 should follow the firm's instructions.
The recalled product
- Product
- Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported…
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Affected units
- 142
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 92810 UDI-DI code
- (01)10841522125751 Software version: 11.6.0
Distribution
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