ACS CDRO64FRecalls & reported problems
American Contract Systems, Inc. · CMC ROBOTIC CDS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072046260), received between May 6, 2019 and May 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
- Material Separation1
- Product Quality Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2019Product Quality Problem; Material Separation; Material Integrity Problem
THE CARILION CUSTOM ROBOTIC DRAPE WITHIN THE PACK TEARS EASILY. ROBOTIC DRAPE SEAM CAME APART ON RIGHT SIDE AT THE TOP OF THE DRAPE AT THE PATIENT'S CHEST AND SPLIT DOWN THE SIDE OF THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8581926 ↗
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- Medline Industries, Inc. DYNJ0842793FMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ38333DMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ50110BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ908124AMedline Industries, Inc. · General surgery tray4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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