Drager Infinity CentralStation Software Temporary Monitoring Functionality Loss
Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.
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: This is an FDA Class II recall of patient monitoring software with a temporary loss of central monitoring functionality. A temporary loss of monitoring capability in a hospital patient-monitoring context presents a potential risk of harm. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Drager Medical Systems, Inc. is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a software issue that causes temporary loss of central monitoring functionality. The software is used for patient monitoring in conjunction with Infinity M300 wireless telemetry devices.
The temporary loss of central monitoring functionality could prevent healthcare providers from monitoring patients through the central station. Approximately 1,950 units have been distributed worldwide, including 376 in the United States across multiple states and 1,574 outside the United States.
The FDA has classified this as a Class II recall. Healthcare facilities using affected software versions should verify that central monitoring functionality is working properly and may contact Drager Medical Systems for information about available updates.
The recalled product
- Product
- Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
- Manufacturer
- Draegar Medical Systems, Inc.
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 (20)
- (01)04049098001878(11)190516(21)1OQ80D-00211(93)MS26800-36
- (01)04049098001878(11)191218(21)1OQ84F-00362(93)MS26800-37
- (01)04049098001878(11)200323(21)1OQ84F-00617(93)MS26800-38
- (01)04049098001878(11)190903(21)1OQ84F-00103(93)MS26800-37
- (01)04049098001878(11)190903(21)1OQ84F-00105(93)MS26800-37
- (01)04049098001878(11)190903(21)1OQ84F-00104(93)MS26800-37
- (01)04049098001878(11)190903(21)1OQ84F-00099(93)MS26800-37
- (01)04049098001878(11)190807(21)1OQ84F-00065(93)MS26800-36
- (01)04049098001878(11)190807(21)1OQ84F-00081(93)MS26800-36
- (01)04049098001878(11)190807(21)1OQ84F-00120(93)MS26800-36
- (01)04049098001878(11)190807(21)1OQ84F-00080(93)MS26800-36
- (01)04049098001878(11)190807(21)1OQ84F-00070(93)MS26800-36
- (01)04049098001878(11)200630(21)1OQ84F-01005(93)MS26800-40
- (01)04049098001878(11)190730(21)1OQ80D-00059(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ84F-00043(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ7XL-00479(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ7XL-00427(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ80D-00010(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ7XL-00792(93)MS26800-36
- (01)04049098001878(11)190730(21)1OQ84F-00088(93)MS26800-36
Distribution
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