Drug recall

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD…

FDA recall event 96791 · Class II · C-RAD POSITIONING AB

Key facts

Event ID 96791
Recall numbers Z-1858-2025
Recalling firm C-RAD POSITIONING AB
Product type Devices
Products Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001)…
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Initiation date Apr 22, 2025
Report date Jun 4, 2025
City Uppsala
Country Sweden
FEI number 3006621300

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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