Twelve foot display cables recalled over inadequate shielding and interference
Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.
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: interference with another medical device in use is a stated patient safety risk, and no injuries are reported.
Plain-English summary
DVI display cables, model/catalog number 012-0895-12, 12-foot DVI-I to DVI-I male/male cables used as an external component with patient monitors, are being recalled.
The display cables used for monitors were not in compliance regarding electromagnetic interference from inadequately shielded cables, which may pose a serious risk to patient safety by interfering with the operation of another electronically sensitive medical device in use.
The recall covers 820 units, associated with monitor UDI-DIs including (01)10841522131479 for Xprezzon. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
Facilities should identify affected cables and follow Spacelabs' instructions for replacement.
The recalled product
- Product
- Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used…
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 820
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 (1)
- (01)10841522131455 (Qube)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Spacelabs Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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