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2026 data FDA MAUDE openFDA FDA Class II

Recorder, Magnetic Tape, Medical

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.2800 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Recorder, Magnetic Tape, Medical LIGHT-BOOK · MAUDE

#678 of 1000 · 962 reports · 1999–2026

  • BOOK 962 reports
  • RANK #678 of 1000
  • DEATH 6 death-typed
  • INJ 860 injury-typed
  • MALF 96 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 215
  • PHOTO Material

Nearest event-volume peer: Material, Tooth Shade, Resin (1 report gap)

Recorder, Magnetic Tape, Medical sits #678 of 1000 among tracked device types with 962 MAUDE reports spanning 1999–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Recorder, Magnetic Tape, Medical carries 89.4% INJURY-coded reports, 59.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 89.4% corpus 30.3% · above corpus mean (+59.1 pp)
  • MALF 10.0% corpus 64.8% · below corpus mean (-54.8 pp)

Lead product-problem code Patient-Device Incompatibility is 46% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 100% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Recorder, Magnetic Tape, Medical in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Recorder, Magnetic Tape, Medical carries 962 MAUDE reports, ranked #678 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 860 (89.4%)
Malfunction 96 (10.0%)
Death 6 (0.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 769 (78.1%)
89 (9.0%)
Other 77 (7.8%)
R 10 (1.0%)
Hospitalization 8 (0.8%)
Life Threatening 8 (0.8%)
Death 6 (0.6%)
O 5 (0.5%)
Disability 4 (0.4%)
D 3 (0.3%)
H 3 (0.3%)
S 3 (0.3%)

Top Product Problems

Patient-Device Incompatibility 425
Use of Device Problem 346
Adverse Event Without Identified Device or Use Problem 46
Patient Data Problem 38
Improper or Incorrect Procedure or Method 9
Patient Device Interaction Problem 7
Loss of or Failure to Bond 6
Other (for use when an appropriate device code cannot be identified) 5
Overheating of Device 5
Insufficient Device Problem Information 4
Output Problem 4
Appropriate Device Problem Term/Code Not Available 3
Biocompatibility 3
Circuit Failure 2
Computer Software Problem 2
Defective Device 2
Device Handling Problem 2
Device Maintenance Issue 2
Device Operates Differently Than Expected 2
Display or Visual Feedback Problem 2

Yearly Trend

99
1999: 2
00
2000: 2
02
2002: 4
05
2005: 1
09
2009: 1
10
2010: 8
11
2011: 3
12
2012: 1
13
2013: 2
14
2014: 3
15
2015: 8
16
2016: 6
17
2017: 31
18
2018: 30
19
2019: 76
20
2020: 91
21
2021: 113
22
2022: 46
23
2023: 65
24
2024: 88
25
2025: 215
26
2026: 166

Reports rose to 215 in 2025, up from an average of 77 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Recorder, Magnetic Tape, Medical

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 7

Event Locations

621 (64.6%)
I 314 (32.6%)
NO INFORMATION 19 (2.0%)
HOSPITAL 5 (0.5%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Recorder, Magnetic Tape, Medical: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (962 here).

Material, Tooth Shade, Resin 961 Alarm, Conditioned Response Enuresis 965 Percutaneously Delivered Prostheses And Tri… 965 Pump, Portable, Aspiration 968

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Recorder, Magnetic Tape, Medical are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Recorder, Magnetic Tape, Medical; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.