FDA Medical Device Recalls (openFDA)
Respironics, Inc.: Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
- Recall number
- Z-1220-04
- Recalling firm
- Respironics, Inc.
- Product
- Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
- Status
- Terminated
- Initiated
- 2004-06-04
- Posted
- 2004-07-27
- Terminated
- 2005-01-06
- Reason
- Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
- Root cause
- Other
- Action
- The recalling firm sent a recall letter to their direct accounts, which include parents and vendors regarding the problem associated with the battery packs. The recall letter advised their customers to check their inventory and if the battery pack is one of the affected recalled product to immediately contact their Customer Service Department. to arrange for replacement battery packs.
- Quantity
- 2726 units
- Distribution
- The recalled product was distributed nationwide and internationally to the folllowing states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV . In regards to foreign accounts, the product was distributed to Canada and British Columbia.
- Lot, serial or model codes
- Model Number 915 Manufacturing Lot Number 45-03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZQ
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- 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