ClearanceBrief
Recall Z-1220-04 ยท BZQ Monitor, Breathing Frequency

Respironics, Inc.

Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.

DateJul 27, 2004 (initiated Jun 4, 2004)
StatusTerminated
ReasonRecalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
Root causeOther
ActionThe 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.
Quantity2726 units
DistributionThe 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 wa
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.