Recall Z-1322-2010 ยท FKP System, Dialysate Delivery, Single Patient
Baxter Healthcare Renal Div
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
| Date | Apr 12, 2010 (initiated Jan 29, 2010) |
| Status | Terminated |
| Reason | Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software. |
| Root cause | Software change control |
| Action | An "Urgent Device Correction" letter dated January 29, 2010 was sent to the direct accounts via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letter informed the accounts that subsequent to a prior device field correction in 2003-2004, some 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. The accounts were instructed to confirm the software version in their systems and replacement boards. Instructions for checking the software version were attached to the letter. A complementary software upgrad |
| Quantity | 443 boards |
| Distribution | Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883111 | HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 Baxter Healthcare Corp, Feb 8, 1989 |