FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.
- Recall number
- Z-2247-2011
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.
- Status
- Terminated
- Initiated
- 2011-04-07
- Posted
- 2011-05-26
- Terminated
- 2013-03-14
- Reason
- Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
- Root cause
- Equipment maintenance
- Action
- The firm, Philips, sent a Field Safety Notice titled "URGENT MEDICAL DEVICE RECALL" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the "Action to be taken by Customer/User" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.
- Quantity
- 25,400 units (1016 boxes)
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Manufactured from October 2010 through February 2011. Product Number: M1923A; Lot Codes: M8330M10 M8386N10 M8411P10 M8451P10 M8477A11 M8514A11 M8572B11 The M1923A Filterline H Set is also shipped as part of the M3015A Measurement Server Extension, Product Option #K33.
- 510(k) numbers
- ["K980327"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28