Endoluminal vision probe bags recalled over compromised sterile pouch seals
Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.
What this means for you
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: a compromised sterile pouch seal on a component used inside the body carries an infection risk, and no injuries are reported.
Plain-English summary
The Ion Vision Probe Bag, model/catalog number 490127, part of the Ion Endoluminal System, is being recalled by Intuitive Surgical, Inc. The record describes the Ion Endoluminal System as a robotically assisted platform for minimally invasive peripheral lung biopsy.
The reason given in the enforcement record is probe bags that may have a compromised or incomplete sterile pouch seal.
The record lists 110,580 units under UDI 00886874119594, GTIN 0886874119594 and part number 490127, with FDA medical device listing number D414014. Distribution covered a wide range of US states listed in the enforcement record. The FDA has classified the action as Class II.
A compromised sterile barrier on a component used in a minimally invasive procedure carries an infection risk. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Intuitive Surgical's instructions.
The recalled product
- Product
- Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
- Manufacturer
- Edan Diagnostics
- Affected units
- 14,550
Distribution
Part of a larger recall action
This product is one of 16 recalled by Edan Diagnostics 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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